The future of pharmaceutical industry now lies with the biotechnology as there is a growing resistance to the use chemical based drugs world over. Biopharmaceuticals or biologics, thus, comprise the fastest growing segment of the pharmaceutical market today. Nearly a quarter of the top 100 drugs in 2007 were biologics, and 13 of them achieved blockbuster status of more than $2 bn in worldwide sales. Many of these drugs will reach patent expiry within the next 10 years, driving interest in biogenerics or biosimilars. Both generic drug manufacturers and large pharma companies are angling for a share of this emerging niche in the $75 bn global market for biosimilars. Generic drug maker, Sandoz, an associate company of Novartis, has already taken the lead on this segment with three biosimilars approved in Europe namely Omnitrope, Binocrit and Zarzio. Teva pharmaceuticals, a leading generics producer, has plans to become a major player in biosimilars. It has one product on the European market (Tevagrastim) and has improved its capabilities in biopharmaceuticals through the recent acquisitions of Barr Pharmaceuticals and CoGenesys, in the US. Teva's strategic partnership with Swiss custom manufacturer, Lonza, to jointly develop, manufacture and market biosimilars confirms its resolve to enter into biosimilar market in a big way. Merck & Co is another serious player in this segment. It has recently established Merck BioVentures and agreed to purchase a portfolio of biosimilar candidates and commercial manufacturing facilities from US-based Insmed, a developer of biopharmaceuticals. Merck has been developing a humanized yeast technology platform since its 2006 acquisition of compatriot GlycoFi. Indian manufacturers such as Ranbaxy, Dr. Reddy's Lab, Biocon and Wockhardt, have also plans to venture into biosimilar market by taking approvals in Europe and, ultimately, in the US.
Biosimilar products do attract a lot of interest and controversy. Because, biological drugs are complicated and expensive and used to treat complex conditions. A key point for developers of biosimilars is the issue of interchangeability. This is going to be a hard sell in the regulated markets where prescribing of chemical generics is already unpopular. The task will be more difficult for biosimilars where worries over equivalence will be greater and less easy to counter. With a regulatory framework already in place in the European Union to address the safety of biosimilars, the opportunity represented by these products has been proven and is growing there. Over 10 biosimilars have been approved in Europe, using the EU's specially adapted approval procedure. In Japan, the first biosimilar has been submitted for review recently. But, the US, the largest pharmaceutical market, is yet to open up for biosimilars as the biotech industry there is strongly opposed to the entry of biosimilar products. Introduction of biosimilars in the US market should bring down the cost of medicine substantially for critical diseases and make them available to a wider population. And that depends on the US government. If the proposed legislation before the US Congress is passed without much changes it should alter the whole look of the global biopharmaceutical industry to the advantage of millions of patients who are now denied of the benefits of advanced but expensive biologics.