Biosimilar development partners Biocon (BSE: 532523) and Mylan (Nasdaq: MYL) have been granted approval for a facility to manufacture Fulphila (pegfilgrastim) for the US market.
The additional approval for the site in Bengaluru, India, will enable Biocon subsidiary Biocon Biologics to scale up capacity to meet demand for Amgen’s (Nasdaq: AMGN) Neulasta copycat in the USA and elsewhere.
The two firms have been working together to target existing and near-term biosimilar opportunities, including high-value biosimilar antibodies Ogivri (trastuzumab) and Mvasi (bevacizumab), referencing Roche’s (ROG: SIX) Herceptin and Avastin, respectively.
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