A biosimilar is a biologic medical product that is almost an identical copy of an original product that is manufactured by a different company. Biosimilars are officially approved versions of original “innovator” products and can be manufactured when the original product’s patent expires. Biosimilars are the generic versions of biologics medicines made from animal or plant proteins as opposed to chemicals.

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Difference between biosimilars and generics:

• Biosimilars involve developing equivalent of biological entity while generics involve developing equivalent of a chemical entity-the Active Pharmaceutical Ingredient.
• In case of biosimilars, biological entities being some ward different (and not as it is of replica), every organism has to be engineered to produce the same therapeutic effect while in generics, the copies of API can be generated
• Bio-similars differ from generics – in complexity, in the manufacturing processes and in the data needed to demonstrate similarity for approval. The structure of Generic Simple and well-defined whereas for Bio-similar its Complex with potential structural variations.
• Regulatory procedure to get approval for biosimilars is complex as compared to that of a generic.

Prospects of Biosimilars:

• The growth of the biologics market for the treatment of cancer (monoclonal antibodies), diabetes (insulin) and many other auto-immune diseases has in turn resulted in creating a global opportunity for biosimilars also.
• Many Indian pharma companies are now making substantial investments into biosimilar development and production for gaining the first mover advantage.
• In 2014, Zydus Cadila became the first company in the world to launch the biosimilar of Adalimumab patented by the US drug major AbbVie, which is being used to treat rheumatoid arthritis and other auto immune disorders.
• As the biologics are priced very high, it is necessary for countries to reduce prices through biosimilars.
• The growth in the biosimilars market is welcome from a human development standpoint because they are more affordable than biologics, the high cost of which often puts them out of reach of many patients.
• In recent times, patents of some biologics have expired and more will expire before 2020. So moving towards biosimilars can fill the gap.
• Targeted towards Non-communicable diseases (cancer, asthma, and arthritis):
  • There is an alarming spike across developing countries in the prevalence of non-communicable diseases.
  • Therefore, promoting the production of complex generics and biosimilars can have a positive development impact given how targeted they are toward treating non-communicable diseases such as cancer, asthma, and arthritis.
• Biosimilars industry can act as a springboard for the pharma companies to innovate, excel and earn profit

Challenges faced:

• The development is itself lengthy and expensive, and could cost more than Rs 100 crore and take up to six or seven years.
• It is hard to generate investor interest if a product hits the market only after seven years. So, India is unlikely to see startups in biosimilars, which could also drive consolidation of some players.
• Expertise in biology is essential, and this subject does not yet have critical mass in India. India has fewer research labs in biology than a big state in Europe or the US. And, yet, things have improved in the last ten years, as experience has built up in technology and regulation.

Way forward:

• Governments can support growth in this segment by clarifying the regulatory framework for them, which is still evolving in many countries. China is a recent example, where the government has identified biopharma, including biosimilars, as a priority area for the country.
• India has to expand the biology research ecosystem by investing in education and fundamental research.
• At the same time, a regulatory mechanism needs to be put in place and appropriate monitoring needs to be done to ensure that unfair and unethical practices are abstained from in preparation of biosimilars.