Biocon and Mylan have won approval in Europe for their substitute of Sanofi’s megablockbuster Lantus and hope to get an FDA nod as well. But the two have hit another manufacturing snag on their march toward an FDA approval.
Biocon announced today that the FDA has issued a Form 483 with half a dozen observations during its first inspection of the plant where the insulin will be produced.
“The US-FDA has completed a pre-approval inspection of our manufacturing facility in Malaysia and issued a Form 483 with 6 observations. As per the normal expectations of the agency, we intend to respond with a corrective and preventive action plan in a timely manner,” the company said in a statement filed with the Bombay Stock Exchange.
The statement gave no indication of the nature of the observations, and the company did not respond to a request for comment. The plant has already won approval from European authorities, which have approved their product for the EU.
While it is unclear how serious any of the observations are, Cyndrella Carvalho, senior research analyst at Dolat Capital in Mumbai, told Bloomberg that given that it is a preapproval inspection and Biocon has time to respond, the Form 483 should not be a big deal.
This is actually the second manufacturing glitch the partners have run into in their effort to get a Lantus copy to the U.S. market. The FDA issued a Form 483 last year for Biocon’s plant in Bangalore where it makes biosimilars as well as the autoinjectors for its insulin products. Biocon downplayed what turned out to be an 8-page, 10-observation critique that found problems across the entire range of processes. It took about 6 months for Biocon to get those issues resolved, and the efforts delayed approval of the partners’ Herceptin biosimilar by three months.
Perhaps a bigger hurdle for Mylan and Biocon in the U.S. will be getting past Sanofi’s patent litigation. The French drugmaker, which saw sales of its top-selling drug fall 17.5% last year to $5.6 billion, sued Mylan last fall claiming the U.S. drugmaker has infringed 18 of its patents with its copy.
Assuming Mylan and Biocon get their approval, they will face competition from already approved copies. Eli Lilly already has a version on the market, and Merck & Co. has one approved, although its launch has been delayed by patent litigation until this year.