Unleashing the Power of India

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

Example: Epoetin, G-CSF, insulin, somatropin

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

Ÿ Marketing approval of biosimilars is a much more complicated issue than approval of generic equivalents of conventional drugs.

Ÿ Stability requires special handling.

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 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.

BiosimilarsBiosimilars

Brief Introduction:

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.

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 Treatment cost with biosimilars is lesser than innovators biological drug.

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

Disadvantages:

Complexity Involved in these Products

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.

www.veedacr.com

Unleashing the Power of India

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

Service Offerings

• BA/BE Studies

• First-in-Human Studies

• 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

• 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

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.

Veeda Clinical Research Pvt. Ltd. – India

For additional inquiries or questions, please contact:

The FDA approvals process for biopharmaceuticals is governed by two different laws and associated pathways.

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.

EU Approval Process for Biosimilars

US Approval Process for Biologics