The global pecking order of blockbuster drugs has undergone a huge shift with seven out of 10 top selling drugs now being biologics .Even the top selling drugs, Humira for rheumatoid arthritis, is a biologic therapy, having toppled Pfizer anti-cholesterol drug Lipitor, the top grossing blockbuster drug for many years. Biologics, also called biopharmaceuticals, have revolutionized treatment in chronic and serious illness like rheumatoid arthritis, cancers and diabetes, and nudged traditional drugs out of the top slots, with sales increasing year on year .As against this drugs which are chemically synthesized have witnessed plunging sales with only Gilead's Harvoni. Being the lone drug to have bettered sales over the last two years. Biologicals are complex molecules manufactured using live organisms as against conventional medicines which are based on chemical composition.

The shift has been witnessed gradually over a decade reflecting the growing commercial dominance of injectable biotech drugs. Over decade ago biologics comprised only 6% of the market with 40% of them being in various stages of clinical development. Earlier in 2010 Pfizer's anti-cholesterol drug Lipitor with global sales of nearly $12 billion was the largest selling drugs but sales started to drop after it lost patent protection. The same year five biologics had also entered the list of top selling drugs.

India too, the biosimilar market across various players is valued at $300- $400 million growing at a CAGR(Compound Annual Growth Rate) of 14%. Several biosimiliars by DRL, Intqas , Biocon , Zydus and Emcure are in the local market with therapies addressing oncology anti-inflammatory, anti-virus, while a small portion is exported. Domestic companies have fast tracked research in biosimilars to tap into the growing potential of biotech drugs globality. With the introduction of a new regulatory policy in India and increased affordability that biosimiliars offer the domestic market is expected to grow at an accelerated pace and reach the target of $40 billion by 2030 to command over 20% share in the global market a recent report.

Siddhi Naik

S. Y. B. Pharm

Tags: MET Institute of Pharmacy