Biocon, which decided to build an insulin plant in Malaysia at a time when India’s infrastructure was looking shaky, says the plant has won approval from European regulators.
The Indian drugmaker says the $275 million plant in Johor, Malaysia, was inspected in April and won an EMA manufacturing certificate to produce active substances, sterile drug products and to handle quality control testing.
The facility already has 600 workers to manufacture recombinant human insulin and insulin analogs in prefilled pens, the company announced Friday. The plant began commercial production this year and is selling insulin in Malaysia, including its biosimilar of Sanofi's Lantus, the top-selling, long-acting insulin in the world.
Biocon says it is its first biopharma processing facility outside of India. Biocon undertook the project in 2010, when India’s economics were shaky. Biocon CEO Kiran Mazumdar-Shaw said several years ago that the drugmaker decided to go outside of its home country for the large plant because of questions over whether India’s infrastructure would be able to consistently provide the power and water the facility would need.
Biocon intends to produce less expensive insulins for global markets. Last year it won approval in Japan for its Lantus biosimilar.
While the EMA is satisfied with Biocon's Malaysia plant, there have been issues with EU regulators over another key Biocon facility. The company pulled its EU application for a Herceptin biosimilar last month after the European Medicines Agency found issues with its biologics product plant in Bangalore.
The regulator told Biocon and partner Mylan that a follow-up inspection would be in order before the Herceptin knockoff and a biosimilar of Amgen’s chemo companion drug Neulasta will be considered for approval. Biocon has indicated it is resolving the EMA concerns and the two companies expect to refile for approval this quarter.
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The FDA has also had issues with the Bangalore plant. Biocon last week reported the the FDA has delayed by three months Mylan's U.S. application for their Herceptin biosimlar, but insisted the delay has nothing to do with manufacturing issues.