Roche Lashes Out At Biosimilars Regulations In Emerging Markets, Calls For Stricter Pharmacovigilance Of Launched Products
This article was originally published in PharmAsia News
Executive Summary
MUMBAI - Roche - maker of blockbuster biotech products like Avastin and Mabthera - has called for a stricter regulatory and approval mechanism for biosimilars being launched in markets like India even as the European Union rolled out its draft guidelines for developing biosimilar versions of complex monoclonal antibodies Nov. 26 (EU Draft Guidelines On Biosimilar Antibodies Go Easy On Generics Firms, But Originators Need Not Panic, The Pink Sheet DAILY, Nov. 29, 2010)
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MUMBAI - Roche - maker of blockbuster biotech products like Avastin and Mabthera - has called for a stricter regulatory and approval mechanism for biosimilars being launched in markets like India even as the European Union rolled out its draft guidelines for developing biosimilar versions of complex monoclonal antibodies Nov. 26 (Also see "EU Draft Guidelines On Biosimilar Antibodies Go Easy On Generics Firms, But Originators Need Not Panic" - Pink Sheet, 29 Nov, 2010.). Thomas Schreitmuller, who heads the Swiss firm's technical regulatory policy and strategy for biologics, told PharmAsia News that given the complex nature of developing and manufacturing a biotech molecule, all biosimilars being developed must undergo step-wise and head-to-head comparisons with the originator's drugs. "Countries adopting the EMA [European Medicine Agency] or those following the WHO criteria will have a robust mechanism in place to allow biosimilars in the market," he said during the BioPharma India convention. Risky Opportunities? The senior Roche speaker also called for devising a systematic pharmacovigilance program in dealing with biotech products in emerging countries like India. Schreitmuller cited a detailed study published in the Journal of the American Medical Association that found roughly 25 percent of 174 marketed biologics prompted safety and regulatory action even after being on the market for years. "The chances of a black box warning for a biotech product is twice as high as compared to a small molecule," he cautioned, adding that compared to a small molecule where a 99.99 percent purity can be obtained in a generic drug, biotech is a mixture of complex proteins and any change in the composition of those properties can endanger patient safety. He praised the EU regulatory agency for allowing biosimilars like G-CSF after a thorough evaluation process of preclinical studies through large-scale human trials. "The regulators have been cautious in not allowing substitutability," he noted. Robust Guidelines Though Roche is not against any of its larger peers entering the biosimilars space, Schreitmuller advocated that serious players should look at improvements and work on biobetters. "Biogenerics do not exist; in best case they could be only similar," he added. Pointing at the WHO guidelines, Schreitmuller said the guidelines were very aptly developed becasue "the non-inferiority clause of a copy of a biotech product does not exclude superiority and superiority could certainly mean inferiority with regard to patient safety." A senior executive from an Indian contract manufacturing and research firm concurred with the Roche executive's views: "It will be a very complex process of trials and approvals and at best only four players can be in the market with very less leeway on reducing prices as the costs of clinical trials will be very high," he noted. Countering Biosimilars Threat When questioned about how Roche would deal with biosimilars and the threat of price reductions on a number of its key oncology drugs, Schreitmuller hinted that his company is observing the changes in the regulatory environment and is gearing up to counter the impending issues. He did not answer a specific question on whether Roche would consider moving some of its manufacturing capabilities to low-cost countries like India. But he said that partnerships and alliances are part of the company's growth ambitions and while Indian companies have developed abilities in handling complex biology, they are still early in their development phase. India Compliant ? On an earlier panel discussion at the same BioPharma India conference, Shrikumar Suryanarayan, director general of the Association of Biotechnology Led Enterprise, said the Indian regulators are intensely studying the biosimilar requirements ascribed by regulators in the EU, Japan and Canada to see if India could meet the standards. India's Dr. Reddy's has emerged as the most active player in the biosimilars space with its latest launch of Cresp - a biosimilar darbepoetin of Aranesp branded by Amgen (Also see "Dr. Reddy's Launches World's First Aranesp Biosimilar In India, Vows To Bring Out More" - Scrip, 9 Aug, 2010.). - Vikas Dandekar ([email protected]) [Editor's note: Elsevier Business Intelligence, publisher of PharmAsia News, will host a virtual conference Dec. 16 highlighting the hottest regulatory/legal topics for 2011 in China, India and the Pacific Rim. Click here for more information and to register for 'Pharmaceutical Challenges and Opportunities in Asia'.] |