Biosimilar is a biologic product, which is very similar to the reference product that has been FDA approved and does not differ much from the reference product with regard to safety and effectiveness.¹ Only the indications and conditions of use that have been approved for the reference drug can be approved for the biosimilar

Biosimilars have been defined in various ways by regulating bodies around the world. Let’s take a look at some definitions:

• World Health Organization (WHO):A similar biotherapeutic product (SBP) is a “biotherapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product”. ²
• US FDA:“A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product”. ³ 

o    In this definition, “no clinically meaningful differences” means that a manufacturer must also demonstrate that its proposed biosimilar product has no clinically meaningful differences from the reference product in terms of safety, purity, and potency (safety and effectiveness). 

o    “Highly similar” means that a manufacturer developing a proposed biosimilar demonstrates that its product is highly similar to the reference product by extensively analyzing (i.e., characterizing) the structure and function of both the reference product and the proposed biosimilar.

• European Union:A biosimilar is a biological medicine highly similar to another biological medicine already approved in the EU (the so-called ‘reference medicine’). ⁴
• Health Canada:Biosimilar biologic drug is “a biologic drug that obtains market authorization subsequent to a version previously authorized in Canada and with demonstrable similarity to a reference biologic drug.” Biosimilars were previously referred to as Subsequent Entry Biologics (SEBs) in Canada. ⁵
• CDSCO:“A Similar Biologic product is a biological product/ drug produced by genetic engineering techniques and claimed to be “similar” in terms of safety, efficacy and quality to a reference biologic, which has been granted a marketing authorization in India by DCGI on the basis of a complete dossier, and with a history of safe use in India.” ⁶

Omnitrope, a somatropin biosimilar was the first biosimilar in Europe to be approved by the European Medicines Agency (EMA) in 2006. ⁷ However, the US FDA approval for the first biosimilar in the country came in 2015, when it approved the first biosimilar to filgrastim, a granulocyte colony-stimulating factor. ¹

The first biosimilar in India was approved in 2000 for hepatitis B. Recently, Herceptin (active drug trastuzumab) became the first biosimilar manufactured in India to be FDA approved for certain breast and stomach cancer. ¹

Biosimilars in India are listed in the Table below. ⁸

References

 1. Meher BR, et al. Biosimilars in India; current status and future perspectives. J Pharm Bioallied Sci. 2019;11(1):12-15.

2. Guidelines on evaluation of similar biotherapeutic products (SBPs), WHO 2009.
3. Biological product definitions, US FDA 2017.
4. Biosimilars in the EU. European Medicines Agency and the European Commission, 2017.
5. Information and Submission Requirements for Biosimilar Biologic Drugs, Health Canada, 2016.
6. Guidelines on similar biologic: Regulatory requirements for marketing authorization in India, 2012.
7. Iughetti L, et al. Long-term safety and efficacy of Omnitrope®, a somatropin biosimilar, in children requiringgrowth hormone treatment: Italian interim analysis of the PATRO Children study. Ital J Pediatr. 2016;42(1):93.
8. Rushvi P, et al. Biosimilars: an emerging market opportunities in India. Pharmaceut Reg Affairs.2016;5:165. 

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA