India is leading the global biosimilar pipeline, with the largest number of products launched in the country and emerging economies. Reliance Life Sciences tops the global pecking order, followed by Intas and Biocon. Biosimilars, developed by innovators, are approved versions of biopharmaceuticals — complex medicines manufactured using live organisms, as against conventional drugs that are based on chemical composition. At present, domestic companies are marketing their products only in emerging markets, but the largest and most lucrative market for all pharmaceuticals — the US — is the next stop. The development not only indicates that Indian pharma companies are moving up the value chain after decades of making copycat medicines, it has, more importantly, led to treatment costs getting slashed by 20-40% in chronic and life-threatening illnesses, like rheumatoid arthritis and cancers.
Data culled from healthcare market research firm IQVIA says domestic companies are on top, and with three proposed launches — tenecteplase, etanercept and human growth hormone — Reliance Life Sciences will consolidate its position with 18 biosimilars over the next few months. Tenecteplase is used to treat myocardial infarction, etanercept for rheumatoid arthritis, and human growth hormone for growth hormone deficiency. “Reliance Life Sciences has pursued a strategy of developing, in an integrated manner, a wide array of biosimilars at competitive prices to meet patient needs on a global basis. Being recognised as the top biosimilar player globally, in terms of number of products, is one testimony of this strategy in practice,” says company president and CEO K V S Subramaniam. However, with regards to biosimilars, there are greater challenges in terms of extensive product characterisation, clinical trials, establishing interchangeability with innovator drugs, dealing with a longer development and regulatory pathway, and a high cost of development, he added. Significantly, the entry of biosimilars has helped bring down prices for patients. To illustrate, net prices to innovators have come down 18% from Rs 22,000 for bevacizumab (a 100mg vial), 45% to Rs 3,000 for interferon beta (30-microgram pre-filled syringe), and 14% to Rs 19,000 for rituximab (500mg vial). Indian companies are exporting biosimilars to developing countries, primarily South Asia, Southeast Asia, Africa and Latin America. Ahmedabad-based Intas Pharma, which has 13 indigenously-developed products in the domestic market, also recently launched its second biosimilar pegfigrastim in the highly regulated European market. It is the only company with two biosimilars ready to be filed for registration in the US, and is already marketing filgrastim, pegfilgrastim and erythropoietin under various brand names in emerging markets, with Accofil (filgrastim) and Pelgraz (pegfilgrastim) in the EU.
Source : https://timesofindia.indiatimes.com
Published on: October 30, 2018