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Biosimilars to replace 70% of chemical drugs in 2 decades
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Biocon China Cipla Dr.Reddy's India Reliance Life Sciences South Korea The Economic Times
Biosimilars are set to replace some 70% of global chemical drugs over the next couple of decades on account of safety parameters and a huge portion of biopharma products going off patent, said a senior government official of India.
Talking to reporters in Hyderabad on Wednesday, director general of Pharmaceuticals Export Promotion Council, PV Appaji, said the chemical drugs will lose preference due to their toxic qualities and side effects.
Saying that the world was looking at introducing safer therapeutic drugs on a large scale, he said at least $80 billion worth biopharmaceutical products were going off patent by 2015 or so, enabling biosimilars reach $10bn from the current $500m.
China is currently leading the emerging global biopharma sector followed by South Korea, while India is hovering at around 3% of global market share. “India will have at least 20-25% market share in biosimilars market over the next five years as more than 100 major Indian pharmaceutical companies are spending largely on research pertaining to biosimilars,” said Appaji.
The Indian pharmaceutical majors that are increasing their research focus on biosimilars include Dr Reddy’s Labs, Biocon, Cipla, Avesthagen, Intas, Reliance life sciences and Wockhardt among others.
Given the significance of biosimilars for the Indian pharmaceuticals sector, the ensuing ‘Bio Asia 2013’ summit is going to accord priority to biosimilars where over 600 companies from more than 50 countries were expected to participate. Further, regulators such as USFDA, EMA and MHRA from over 20 countries would discuss issues pertaining to regulatory challenges, said Appaji.
Bio Asia chief executive Shakti M Nagappan said several private equity and venture capital players were also set to attend the conference, which is scheduled to be held in Hyderabad from January 28-30.
Source: The Economic Times
5:19 PM
Biosimilars replacing not just the majority, but 70% of chemical agent-based drugs! Even if he misspoke and meant to refer to all biopharmaceuticals, that is simply ridiculous! And when ireferring to biosimilars, he is obviously (must be) primarily referring to low(er)-end biogenerics, not products approved/approvable in the US, EU and other highly-regulated markets as genuine biosimilars.
I do not foresee any, or at most no more than say 2-3 (outliers/exceptions), Indian companies manufacturing biopharmaceuticals for marketing in highly-regulated countries (the major biopharmaceutical markets) for at least a good part of a decade. And with India increasingly expropriating intellectual property, canceling patents, not granting process patents, granting compulsory licenses, etc., it will increasingly be left behind using older, legacy, off-patent technologies (e.g., what company will be able trust Indian companies to transfer to them their newest, best bioprocessing technologies)?
Yes, India may well become the world leader in biogeneric-type products for its own and international markets, which is what the country seems to be targeting, but that will always just be a relatively small portion of the much larger biopharmaceuticals market. If nothing else, the very low prices Indian manufacturers will presumably charge will restrict their market size and share. Otherwise, genuine biosimilars, i.e., those approved in highly-regulated countries as biosimilars, will surely be a larger market than the lesser-regulated countries-targeted biogenerics.