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Biosimilars- revised


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									Follow-on Biologics/ Biosimilars
Organization                                 Issue               Position
Amgen                                        Labeling              Urges policymakers to require labels on biosimilars denote all the ways it differs from
                                                                      the brand it references
                                                                   Seeks to have different common names- often referred to as generic names, assigned
                                                                      to biosimlars
                                                                   Labels should indicate that the FOB as a biosimilar and list the safety efficacy of the
                                                                      clinical trials the FOB conducted to get approval
Association of American Universities (AAU)   Patent                Lobbying for patent resolution that allows universities to be included when brand and
                                             infringement             generic biological drug makers begin patent disputes ( as research universities have
                                                                      several FOB patents)
                                                                   Support H.R. 5629 as it allows for third parties to be involved in patent litigation and
                                                                      the ability to sue biogenerics for patent infringement
Biotechnology Industry Organization (BIO)    Patent litigation     Favors litigation patent disputes should take place concurrently with the FOB approval
                                             and approval             process and prior to launch
                                                                   Claims that large investment is needed to develop FOB which would allow only the
                                                                      most financially strong companies to be able to afford to lose the return on
                                                                      investment until after approval to resolve disputes
                                                                          o Disadvantage smaller, financially weaker companies
                                                                   Approval of FOB should be effective on date of reference product’s patent expiration
                                                                   Legislation should encourage bringing FOB to market rather than challenging patents
                                                                   Two biologics made by different manufacturers with different processes will not be
                                                                      the same, therefore patent litigation for one FOB will not necessarily apply to another
                                                                   If patent is upheld in court, there should be no approval decision until patent expiry.
                                             Cost                  Claims that putting FOB and reference brands in the same Medicare Part D billing
                                                                      codes would penalize physicians who dispense brand products regardless of efficiency
                                                                      or patient safety
Generic Pharmaceutical Association (GPhA)    Patent litigation     Suggests that only those patent disputes that would delay generic marketing to be
                                             and approval             litigated should simultaneously be in the FDA review process
                                                                   Marketing exclusivity provides incentives needed for generic companies to undertake
                                                                      the risk of intellectual property
                                             Pathway               Seeks a pathway for FOB that would allow the FDA to have the authority to review
                                                                      and approve biogenerics and determine requirements for clinical trials on a case-by-
                                                                      case basis
Insmed (pharmaceutical company)              Pathway               Seeks to be first U.S based company with an extensive biogenerics portfolio
                                                                   Encourages Congress to establish legislation that would allow “pathway for
                                                                      biogenerics that gives the FDA authority and flexibility”
                                                                          o FDA should be able to determine scientific and data requirements on a case-by-
                                                                             case basis
                                                                    As small biotech firm, supports H.R. 1038 which allows for competition among
                                                                     biologics manufacturers
                                                                    Commissioned report finding a 20 year savings between $236- $378 billion and
                                                                     contends the demand for biogenerics is extremely high
Novartis                                     Patent litigation      Contends that FOB should face patent challenges AFTER FDA approval
                                             and approval                o Claims pre-approval challenges undermine competition and access
                                                                    Upon approval, sponsors must notify reference product BLA holder and delay market
                                                                     entry for 45-90 days to allow for the same patent litigation as all other FDA- approved
                                                                    Exclusivity to first FOB would encourage interchangeability status which is considered
                                                                     to be the most effective way for head- to -head market competition.
                                             Competition            Lack of formal designation of biosimilar as substitutable is likely to lead to substitution
                                                                     across the “class”
Pharmaceutical Care Management Association   Competition            Cites German Experience:
                                                                         o Country has experienced significant competition upon entrance of FOB as sales
                                                                             from biosimilars grew to approximately $25 million
                                                                    Suggests that reference product manufacturers will likely lower prices and increase
                                                                     marketing in response to biosimilars.
Wyeth                                        Patent litigation       Proposed 10 years of data exclusivity followed by four years of market exclusivity
                                             and approval            allowing generic companies 48 months to file an application and resolve patent
Zuckerman Spaeder (represents generic        Patent litigation      Contends that there is a need for a method to resolve patent disputes. He claims that
companies)                                   and approval            the goal should be to have all patent issues that may preclude marketing be resolved
                                                                     prior to the day the biosimilar is ready to be approved.
Organization/ Individual                     Issue            Position
World Health Organization (WHO)              Data               Further information is needed for clinical trials to support license applications for FOB
    Expert Committee on Biological          Requirements       Seeks to provide approval agencies with guided/concrete principles for the two
       Standardization                                             pathways( biosimilars, clinical comparability) used for approval
                                                                      Guidelines should be clarified so regulators know pathways apply to only well-
                                                                         established and well-characterized proteins derived from modern molecular
                                                                         biological methods
                                             Pathway            Two proposed approaches for an abbreviated approval pathway for biogenerics :
                                                                     1. Require manufacturers to show safety and efficacy comparable to an approved
                                                                         reference product in head-to-head trials and would allow the labels of FOB to
                                                                         match all indications on reference products
                                                                     2. Clinical comparability approach- allows clinically comparable biologics to be
                                                                         approved even if they do not contain active ingredients similar to reference
                                                                         product and would not require head-to-head trials
Congressional Budget Office (CBO)            Cost               Estimates savings of $12 billion if CMS were to change Part B reimbursement rules for
                                                                Placing biosimilars under the same billing codes as reference products would decrease
                                                                   Average Sales Price allowing for physicians who use the cheaper FOB to profit by
                                                                   saving the difference between cost and reimbursement
                                                                New Part B modification would penalize physicians for using brand biologics rather
                                                                   than FOB
Food and Drug Administration                 Labeling           Changing the International Nonproprietary Names (INN) for biosimilars should depend
                                                                   on molecular characteristics and class of ingredients ONLY
                                                                INN’s for biosimilars should not indicate interchangeability without scientific data

Federal Trade Commission (FTC)               Patent              Concerned that awarding period of marketing exclusivity to the first FOB may be
                                             litigation and       abused
                                             approval            Biogeneric exclusivity would depend on degree of interchangeability determined for
Medicare Payment Advisory Commission         Pathway             Urges Congress to pass legislation allowing FDA to approve generic biologics.
(MedPAC)                                                            o legislation could inject competition to the ESA market and reduce Medicare’s
                                                                        annual cost for ESAs
Rep. Henry Waxman (D-CA)                     Pathway             Crafted Life-Saving Medicines Act, H.R. 1038
Chairman, Committee on Energy and Commerce                          o Creates an abbreviated pathway for FOB
                                                                    o Would not set predetermined exclusivity period for innovator products
Senator Ted Kennedy (D-MA)                   Pathway             Sponsored S. 1695
Chairman, Committee on Health, Education,                           o Would give innovators 12 years to market exclusively
Labor and Pensions
Senator Max Baucus (D-MT)                                        Supports the idea of generic biologics because it would increase access to biologics
Chairman, Finance Committee                                       and save the health care system billions of dollars
Companies entering the Biosimilars Market
Organization                      Progress
Merck (BioVentures division)        plans to launch Merck BioVentures which aims to launch six or more FOB between 2012 and
                                    Plans to spend approximately $1.5 billion in R&D through 2015
                                    Already has an FOB in development, a sugar-modified drug for anemia

Eli Lilly                            completed a $6.5 billion purchase of biotechnology company ImClone Systems

AstraZeneca                          Pharma company is “looking at developing lower-cost versions of its rivals' expensive biological
                                      medicines as soon as they go off-patent” in 2012
Sandoz (division of Novartis)        division of Novartis dedicated to production of off patent pharmaceuticals
                                     developed generic follow on protein drug, Omnitrope designed for growth disorders and was
                                      approved by the FDA in 2006
                                      developed Binocrit, the first ESA (erythropoiesis stimulating agent) go be granted marketing
                                      authorization and approval in Europe

Teva Pharmaceuticals                 Israeli based company is the world’s largest generic pharmaceutical manufacturer and recently
                                      acquired Barr Pharmaceuticals and SICOR- a leading biogenerics firm and CoGenesys, a firm
                                      specializing in fusing human albumin with biological molecules
                                     Hopes to have first biogeneric in Europe in 2009 and broad market penetration in 2013

Momenta                              Massachusetts based company specializing in sequencing and design of complex sugars to
                                      duplicate existing biopharmaceuticals
                                     Often partners with Sandoz

BioPartners                          Switzerland based company
                                     Developed Valtropin, a human growth hormone drug passed by Europe’s Medical Commission
                                      in 2006

Dr. Reddy’s Lab                      Has begun development on Biologics lab for sole purpose of developing FOB

Insmed (pharmaceutical company)      Seeks to be first U.S based company with an extensive biogenerics portfolio
  Key Legislation
Bill                  Guidelines                                     Interchangeability / Class- Specific   Exclusivity                       Patent/ Infringement
H.R. 1427-            Term biosimilars indicates that there are no   Applicant may submit information       Biosimilar exclusivity:
Promoting             clinically meaningful differences between      to the Secretary to demonstrate
Innovation and        the biological product and reference product   interchangeability and request             5 year exclusivity
Access to Life-       in terms of safety, purity and potency         determination
Saving Medicine
                                                                     Secretary shall make one of
Act                                                                  following determinations upon              3 year extension for
                                                                     issuing biologic product license:           modified versions
Sponsor: Rep.                                                          Product is interchangeable
Henry Waxman (D,                                                           with reference product for           Additional 6 months if
CA-30)                                                                     one or more condition(s)              manufacturer conducts a
March 11, 2009                                                             specified in the labeling             pediatric study
                                                                       Interchangeability has not
                                                                           been established, however,
                                                                           product IS AS safe and
                                                                           effective as for approved uses
                                                                           as the reference product
H.R. 5629-            Any person may submit an application for       Secretary will determine if            Biosimilar exclusivity            Allow third parties (i.e. universities who
Pathway for           licensure of biological products.              biosimilar is interchangeable with        24 month exclusivity for      hold patents) opportunity to enter patent
Biosimilars Act                                                      reference product:                          first approved               dispute and take action against patent
                      Product is required to demonstrate it is         FOB can be expected to                   interchangeable biosimilar   infringement
Sponsor: Rep. Anna    biosimilar from data:                                produce clinically equivalent
Eschoo (D- CA -14),       “highly similar”                                results for each condition       Reference Product
March 13, 2008            Animal studies                                  suggested for reference            12 years after reference
                          Demonstrate safety, purity and                  product                               product was licensed
                             potency                                   No risk in safety or efficacy in
                      FOB must:                                            alternating or switching
                          Treat same condition(s) that have               biosimilar and reference
                             been approved for reference
                          Require same administration and
                             dosage must be the same as
                          Facilities must meet all standards
S. 1695-             Any person may submit an application for           Application may request          If another FOB has been            Reference sponsor:
Biologics Price      licensure of biological products.                   determination of                 deemed interchangeable to         o 60 days after receipt of application,
Competition and                                                          interchangeability               same reference product as              must provide list of patents that
Innovation Act of    Product is required to demonstrate it is          Secretary may determine           applicant, Secretary will not          sponsor deems infringement is possible
                     biosimilar from data:                               interchangeability if FOB:       make determination until:          Applicant:
                         “highly similar”                              o FOB can be expected to         o 1 year after first commercial      o 60 days after receiving list from
Sponsor: Sen. Ted        Animal studies                                     produce clinically               marketing of first FOB               sponsor must provide detailed
Kennedy (D-MA),          Demonstrate safety, purity and                     equivalent results for each o 18 months after final court             description of the factual and legal
                            potency for 1 or more condition of               condition suggested for          decision of infringement or          basis for invalid or unenforceable
June 26, 2007
                            reference                                        reference product                dismissal of action against          patent infringement claims
                     FOB must:                                          o No risk in safety or efficacy       applicant                       Sponsor reply:
                         Designed to avoid duplicative or                   in alternating or switching o 42 months after first                  o 60 days to describe why patent
                            unethical testing                                biosimilar and reference         interchangeable approved if              will be infringed
                         Use same mechanism(s) of action for                                                 applicant has been sued and After sponsor and applicant agree on list of
                            condition(s)                                                                      litigation is still ongoing    patent In question, sponsor has 30 days to
                         Treat same condition(s) that have                                              o 18 months after approval of       take action for patent infringement
                            been approved for reference                                                       first interchangeable if
                         Require same administration and                                                     applicant has not been sued    Applicant must notify reference sponsor at
                            dosage must be the same as                                                    Reference exclusivity is 12 years least 180 days before date of first
                            reference                                                                     to the date reference product      commercial marketing
                         Facilities must meet all standards                                              was licensed
                                                                                                         o Application may not be            Prior to first marketing, sponsor may seek
                     By October 1, 2012- Collection of fees will be                                           submitted until 4 years after preliminary injunction prohibiting
                     associated with submission of application                                                reference license date         marketing or sales of FOB until court
                                                                                                                                             decides validity of infringement

S. 1505-             Any person may submit an application for         Product- Specific Rules               First Biosimilar: 1 year         Patent holder :
Affordable           licensure of biological products.                                                      exclusivity                       o may request information from
Biologics for                                                         Application must show:                                                      applicant to discover if FOB or
Consumer Act         FOB must demonstrate:                             o consistency and robustness of                                            processes would be infringed
                      o Conforms to applicable final product               manufacturing process for                                          o provide applicant a notice of patents
                         class- specific rule and data proving             active ingredients                                                     that may be infringed
Sponsor: Sen. Judd
                         safety, purity and potency                    o stability, compatibility and                                         o indicate whether holder is willing to
Gregg (R-NH),
                      o Similar to reference product                       biological integrity of active                                         license patent rights on a non-
May 24, 2007
                      o Same administration and dosage                     ingredient(s)                                                          exclusive basis
                         requirements                                  o show physical , chemical and
                      o Facilities must meet same standards                biological elements
                      o Treat same condition(s) suggested for              characterizing FOB with
                         reference product                                 reference
                      o Final FOB is applicable to class- specific     o Comparative nonclinical
                         rule                                              studies demonstrating
                                                                           reference and FOB have
                     Biosimilars Advisory Committee                        similar profiles
                      o Established by the Secretary                       (pharmacokinetics, toxicity,
                      o Committee is to provide expert advice              immunogenicity, etc.)
                          and recommendations to the Secretary         o comparative clinical trials
                      o Secretary may appoint members with                 demonstrating safety, purity
                          relevant expertise and diverse             and potency
                          experience                            o    post market assessment and
                          Scientific, industry and consumer         monitoring
                              organizations may nominate

H. R. 1038-          Any person may submit an application for   Requires demonstration that             Biosimilar relying on reference    Applicant may request for patent
Access to Life-      licensure of biological products.          biosimilar is “comparable or            for which another biosimilar has   information from holder of reference
Saving Medicine                                                 interchangeable” to reference           been determined                         o Holder has 60 days to provide list
Act                  FOB must demonstrate:                         o Comparable: absence of             interchangeable will not be                of all patents holder owns or is
                      o FOB is comparable to or                        clinically meaningful            considered until:                          licensed
Sponsor: Rep.            interchangeable with reference                differences                           o 180 days after first
Henry Waxman          o Utilization of same mechanism(s) of        o Interchangeable:                            commercial marketing      After submission, applicant may provide
(D,CA-30) Feb. 14,       action for condition as reference              o FOB can be expected to             o 1 year after court          notice to the patent holder of the
2007                  o Reference product previously approved                 produce clinically                 decisions on all patent   reference product
                         for condition(s)                                     equivalent results for             infringements against
                      o Administration and dosage remain the                  each condition                     applicant or dismissal    Within 45 days, holder/owner may bring
S. 4016
                         same as the reference                                suggested for                      of application            action for infringement of only the patents
Sponsor: Sen.
                      o Facilities must meet same                             reference product                  submitted by applicant    listed in notification
                         requirements                                   o No risk in safety or                   for first FOB
                                                                              efficacy in alternating        o 36 months after
                                                                              or switching biosimilar            unresolved litigation
                                                                              and reference                  o 1 year after approval
                                                                                                                 without litigation

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