GMP Lapses At Biocon’s Indian Site – Jitters for Neulasta Biosimilar Plans?
Biocon’s facility in Bangalore, India, has failed to pass muster with the US FDA, raising questions on whether this could result in a pushback of commercialization timelines for partner Mylan’s biosimilar pegfilgrastim in the US. The European regulator has also not cleared the Bangalore site.
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Biocon is building on its alliance with Mylan and the partners are adding biosimilar programs for insulin glargine 300 units/mL and pertuzumab to their pipeline. But there's little clarity on the duo's ongoing program for biosimilar adalimumab in the backdrop of Mylan's recent deal with Fujifilm Kyowa Kirin Biologics for its product.
A biosimilar of Amgen's Neulasta appears on track for FDA approval by the June 4 action date, management said during an investor briefing that showcased Mylan's expansive biosimilar pipeline. Mid- to late-stage copies of products like Advair, Symbicort, Herceptin, Humira, Avastin, Rituxan, Eylea and Botox highlight the strategic direction Mylan moved in nearly a decade ago.
By carrying out certain corrective and preventive actions, a Biocon facility in Bangalore, India, averted an "official action indicated" finding US FDA officials had proposed in an establishment inspection report, one that could have potentially delayed approval of two Mylan biosimilars. Key issues at the site included visible particles in sterile injectable drug products as well as various aseptic processing practices.