Biosimilars are protein drugs that are similar but not identical to existing biologic products whose patents have expired. They offer potential cost savings compared to innovator biologics but are more complex than traditional generics. Developing biosimilars requires extensive clinical testing to demonstrate similarity due to biologics' sensitivity to manufacturing processes. Regulatory approval pathways for biosimilars are more complex than for generics and involve demonstrating similarity rather than just bioequivalence.

1. Biosimilars
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
Advantages:
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
Disadvantages:
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

2. 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
pathways.
• 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
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
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
biosimilars.
For additional inquiries or questions, please contact:
Veeda Clinical Research Pvt. Ltd. – India
India • UK • USA • Belgium • France • Malaysia • Japan
www.veedacr.com