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Biosimilars Brief Introduction: Biosimilar is the term coined for protein drugs that are similar, but not identical to, an existing product. Copies of biopharmaceuticals (proteins) that can be made after the patent on the original product has expired

Ÿ The required capital investment in property, plant, and equipment and the costs of manufacturing will be much higher for biosimilars than for generic drugs. Ÿ Most have no pharmacopeia monographs.

Example: Epoetin, G-CSF, insulin, somatropin

Complexity Involved in these Products Advantages: Ÿ The operating profit margin of traditional generic drugs is roughly 20%, but depending on the biosimilar product, profit margins have the potential to be somewhat higher, as much as 30%.

Ÿ Biological drugs are far more complex than conventional small

molecule pharmaceutical products. Ÿ The complexity of biological drugs also comes from the

elaborate manufacturing processes involved in their production. Ÿ A major concern with biological drugs is immunogenicity,

Ÿ Treatment cost with biosimilars is lesser than innovators biological drug.

Immunogenicity can be affected by various factors including manufacturing processes and impurities.

Ÿ Biopharmaceuticals represent one of the fastest-growing segments of pharmaceuticals industry and by 2011, they are expected to represent 50% of the market.

Ÿ Marketing approval of biosimilars is a much more complicated

Ÿ Patent of original product is going to expire and therefore opportunity for gereric versions of biopharmaceutical is very large.

Ÿ Stability requires special handling.

issue than approval of generic equivalents of conventional drugs.

Ÿ Highly sensitive to manufacturing changes. Ÿ Extensive clinical trials, including Phase I and Phase III studies.

Disadvantages: Ÿ Biosimilars are less stable than chemical based pharmaceuticals and thus require cold chain distribution and have a shorter shelf life. This increases the cost and complexity of distribution. Ÿ The cost of development will be significantly higher than for chemical-based generics.

Verifying similarity or comparability of a biosimilar with an innovator product therefore requires much more than demonstrating bioequivalence (which is sufficient for conventional generic drugs.) Ÿ As the complexity of the protein product increases, such as with

long-chain or heavily glycosylated proteins and monoclonal antibodies, more clinical data are required to fully characterize 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 pathways.

• BA/BE Studies • First-in-Human Studies

Ÿ Majority of biopharmaceutical products are approved through Public Health Service Act (PHSA section 351) and biological license application. But ,there is no abbreviated pathway for approval of Generics . No existing statutory framework for approval of biosimilars.

Ÿ New Drug Applications governed by Federal Food, Drug and Cosmetic Act (FFDCA). Hatch-Waxman provisions provides an abbreviated new drug application (ANDA) pathway for generic small molecule drugs. Section 505(b) (2) of FDCA allows FDA to review and approve the same. Some protein drugs like insulin and human growth hormone are regulated under FFDCA.

• PK/PD Studies • Phase 1/2a • PK Studies (Dose Response, Steady State, Food Effect, DDI) • Controlled Substance studies • QTc Studies • Renal Studies • Glucose Clamp Services • Bio-Analytical Services for Small Molecules • Method Development and Validation • Japanese Bridging Studies • Pharmacovigilance Support Services

The Veeda Difference • India’s most experienced early clinical development CRO • Not connected or owned by any pharmaceutical company and entirely focused on Clinical Research • Operations in India, UK, USA, Belgium, France Malaysia, and Japan • Very low attrition rate

EU Approval Process for Biosimilars

Ÿ All applications for marketing authorization pertaining to biotechnology medicines, including biosimilars biotechnology-derived medicines are submitted to European Medicines Agency (EMEA) for assessment.

Ÿ After review of the application by EMEA, based on evaluation of quality , safety and efficacy they award either a positive or negative opinion.

Ÿ After getting a positive opinion on the product, European Commission (EC) will grant marketing authorization valid for the European Union, who is the final decision maker for marketing approval of biosimilars.

• 6 successful US FDA Audits • 2007 Frost and Sullivan's "Partner of Choice" for Phase I studies • 2009 Frost and Sullivan’s “Indian Clinical Research Organization of the Year’’ • Trusted CRO partner to 11 of the world’s top 15 Global Pharmaceutical Companies

For additional inquiries or questions, please contact:

Veeda Clinical Research Pvt. Ltd. – India

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

Biosimilars Advantages and Disadvantages  
Biosimilars Advantages and Disadvantages  

Biosimilar is the term coined for protein drugs that are similar, but not identical to, an existing product. Copies...