A large Protein molecule typically derived from living cells and used in the treatment or prevention of diseases. Include therapeutic proteins, DNA, monoclonal antibodies and fusion proteins. Often 200 to 1,000 times the size of a small molecule drug and far more complex structurally.
Biosimilars are legally approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent & exclusivity expiry of the innovator product. Because of structural & manufacturing complexities, these biological products are considered as similar, but not generic equivalents of innovator biopharmaceuticals. In simple terms Biosimilars are non-innovator or copy products of the original biologic drug and are also cheaper.
DEFINITION OF BIOSIMILARS:
1. By WHO
SBP (Similar Biologic Product) A biotherapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product.
2. BY US FDA
FOB (Follow-On Biologic)
A biological product that is highly similar to a U.S. licensed reference biological product with no clinically meaningful differences in terms of the safety, purity and potency.
Unlike generic medicines where the active ingredients are identical, biosimilars – by definition are not likely to be identical to the originator biologic. Similar to Snowflakes Biologics made by different manufacturers differ from the original product and from each other.
The development of biosimilars allows for wider and, as important, earlier access to these agents because of their lower cost and consequently greater affordability. Lower cost is expected not only to improve cost efficacy ratios, but also to improve drug access.
Hence Biosimilars require thorough testing
Ranbaxy lauched Indias first Biosimilar of Infliximab – Infimab in Dec 01 2014
Etanercept - Etacept
Intas launched biosimilar version of Rituxumab – Mabtas in India in April 2013 in order to make treatment of NHL cost effective.
According to a recent report by Morgan Stanley, as many as nine drugs in the biologics category have either gone off patent or will do so by 2025. Their total revenue was $62 billion (around Rs 4.3 lakh crore) in 2018. This creates a major opportunity for their respective biosimilars. The research firm estimates that revenue of these biosimilars will grow by 24 per cent annually for seven years to $13.3 billion in 2025 (around Rs 93,000 crore) in the US and Europe. That offers a big opportunity.
According to a report by Associated Chambers of Commerce of India (Assocham), the global market for biosimilars will be $240 billion and the Indian market will be over $35 billion by 2030. Indian pharma companies including Biocon, Glenmark Pharmaceuticals, and Zydus Wellness are actively focusing on the biosimilars market. Biocon, for instance, earned Rs 1,517 crore or nearly 28 per cent revenue from biosimilars in FY19.
Biosimilars entry in to the Indian market In India, biosimilars are called as "similar biologics". India has come a long way since the first "similar biologic" was launched in 2000 for hepatitis B when no specific guidelines had been established for approval and marketing of a biosimilar in India. .
The active partake of the Indian companies in the biosimilars space is seen by the fact that 201 active biosimilars are in the pipeline of 52 Indian companies.
A report by of Associated Chambers Commerce of India (Assocham) predicts that by 2030 the global market for biosimilars will have reached $240 billion and the Indian market will be at a booming $35 billion . If the figures are right, this indicates that the Indian market is ripe, lucrative and full of potential, still left to be explored.
Another report by Association of Biotechnology Led Enterprises (ABLE), India’s biologics market will grow at a compound annual growth rate (CAGR) of 22 percent to hit $12 billion by 2025.
98 biosimilars were approved by September 2019.
Demand in Europe and the USA is expected to sustain longer term growth rates as these markets open-up further to biosimilar encroachment and encourage new entrants. Undoubtedly, the lower cost of manufacturing in India makes biosimilars exports attractive to Western markets though initial market entry may be slowed by high clinical development costs. Data also suggests that 2019 will see a larger number of Western-Indian partnerships bringing new biosimilars to patients in both the EU and USA.
The research highlighted that unlike its small molecule industry – which improved rapidly in the 2018 league tables – the bio industry in India is still viewed by international pharma as substantially behind the leading markets in terms of quality and innovation. Notably, the top ranked nations of the United States, Germany, and Japan, and the second tier of advanced nations, Sweden, Ireland, Switzerland, the UK, France and Korea.
But our Problem is quality and innovation ,read the comment below
However, data from CPhI shows that India also received the second lowest overall scores for ‘quality of biologics manufacturing’ and ‘biologics innovation
Humira, Remicade, Enbrel, Aranesp, Rituxan, Sandoz, Teva, Hospira, Pfizer, STADA Arzneimittel, Mylan, 3SBio, Qilu Pharmaceutical, Shanghai Fosun Pharmaceutical, Biocon, Dr. Reddy's Laboratories, Probiomed, Biosidus, Celltrion, LG Life Sciences.
Profiles of leading biosimilar companies based in the rest of the world: