Biosimilars Advantages and Disadvantages by veedaoptz


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Brief Introduction:
                                                                     Ÿ The required capital investment in property, plant, and
Biosimilar is the term coined for protein drugs that are similar,      equipment and the costs of manufacturing will be much higher
but not identical to, an existing product. Copies of                   for biosimilars than for generic drugs.
biopharmaceuticals (proteins) that can be made after the              Ÿ Most have no pharmacopeia monographs.
patent on the original product has expired
Example: Epoetin, G-CSF insulin, somatropin
                                                                    Complexity Involved in these Products
                                                                     Ÿ Biological drugs are far more complex than conventional small
 Ÿ The operating profit margin of traditional generic drugs is         molecule pharmaceutical products.
   roughly 20%, but depending on the biosimilar product,             Ÿ The complexity of biological drugs also comes from the
   profit margins have the potential to be somewhat higher,             elaborate manufacturing processes involved in their production.
   as much as 30%.
                                                                     Ÿ A major concern with biological drugs is immunogenicity,
 Ÿ Treatment cost with biosimilars is lesser than innovators            Immunogenicity can be affected by various factors including
   biological drug.                                                     manufacturing processes and impurities.
 Ÿ Biopharmaceuticals represent one of the fastest-growing           Ÿ Marketing approval of biosimilars is a much more complicated
   segments of pharmaceuticals industry and by 2011, they               issue than approval of generic equivalents of conventional
   are expected to represent 50% of the market.                         drugs.
 Ÿ Patent of original product is going to expire and therefore       Ÿ Stability requires special handling.
   opportunity for gereric versions of biopharmaceutical is
   very large.                                                       Ÿ Highly sensitive to manufacturing changes.

                                                                     Ÿ Extensive clinical trials, including Phase I and Phase III studies.
                                                                        Verifying similarity or comparability of a biosimilar with an
                                                                        innovator product therefore requires much more than
 Ÿ Biosimilars are less stable than chemical based                      demonstrating bioequivalence (which is sufficient for
   pharmaceuticals and thus require cold chain distribution             conventional generic drugs.)
   and have a shorter shelf life. This increases the cost and        Ÿ As the complexity of the protein product increases, such as with
   complexity of distribution.                                          long-chain or heavily glycosylated proteins and monoclonal
 Ÿ The cost of development will be significantly higher than            antibodies, more clinical data are required to fully characterize
   for chemical-based generics.                                         the clinical properties of biosimilars.

                                                                                                Unleashing the Power of India
                                                                                                    Unleashing the Power of India

US Approval Process for Biologics
                                                                                                                   Service Offerings
The FDA approvals process for biopharmaceuticals is governed by two different laws and associated                  • BA/BE Studies
                                                                                                                   • First-in-Human Studies
 Ÿ Majority of biopharmaceutical products are approved through Public Health Service Act (PHSA                     • PK/PD Studies
    section 351) and biological license application. But ,there is no abbreviated pathway for approval of
    Generics . No existing statutory framework for approval of biosimilars.                                        • Phase 1/2a
                                                                                                                   • PK Studies (Dose
 Ÿ New Drug Applications governed by Federal Food, Drug and Cosmetic Act (FFDCA). Hatch-Waxman                       Response, Steady State,
    provisions provides an abbreviated new drug application (ANDA) pathway for generic small molecule                Food Effect, DDI)
    drugs. Section 505(b) (2) of FDCA allows FDA to review and approve the same. Some protein drugs                • Controlled Substance
    like insulin and human growth hormone are regulated under FFDCA.                                                 studies
                                                                                                                   • QTc Studies
                                                                                                                   • Renal Studies
                                                                                                                   • Glucose Clamp Services
                                                                                                                   • Bio-Analytical Services
                                                                                                                     for Small Molecules
                                                                                                                   • Method Development
                                                                                                                     and Validation
                                                                                                                   • Japanese Bridging
                                                                                                                   • Pharmacovigilance
                                                                                                                     Support Services

                                                                                                                    The Veeda Difference
                                                                                                                   • India’s most experienced
                                                                                                                     early clinical development
                                                                                                                   • Not connected or owned
                                                                                                                     by any pharmaceutical
                                                                                                                     company and entirely
                                                                                                                     focused on Clinical
                                                                                                                   • Operations in India, UK,
                                                                                                                     USA, Belgium, France
                                                                                                                     Malaysia, and Japan
                                                                                                                   • Very low attrition rate
                                                                                                                   • 6 successful US FDA
EU Approval Process for Biosimilars                                                                                  Audits
                                                                                                                   • 2007 Frost and Sullivan's
 Ÿ All applications for marketing authorization pertaining to biotechnology medicines, including                     "Partner of Choice" for
    biosimilars biotechnology-derived medicines are submitted to European Medicines Agency (EMEA)                    Phase I studies
    for assessment.                                                                                                • 2009 Frost and Sullivan’s
                                                                                                                     “Indian Clinical Research
 Ÿ After review of the application by EMEA, based on evaluation of quality , safety and efficacy they                Organization of the Year’’
    award either a positive or negative opinion.                                                                   • Trusted CRO partner to 11
                                                                                                                     of the world’s top 15
 Ÿ After getting a positive opinion on the product, European Commission (EC) will grant marketing                    Global Pharmaceutical
    authorization valid for the European Union, who is the final decision maker for marketing approval of            Companies

                                     For additional inquiries or questions, please contact:

                                            Veeda Clinical Research Pvt. Ltd. – India

                                           India • UK • USA • Belgium • France • Malaysia • Japan


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