Asia’s largest integrated insulins facility, operated by a subsidiary of Biocon in Malaysia, receives GMP compliance certification from Ireland’s HPRA.
Three biosimilar products submitted to the EU for approval have suffered a setback after regulators found 35 GMP deficiencies at Biocon’s fill/finish facility in Bangalore, India.
Biocon has been awarded a three-year contract to supply recombinant human insulin formulations made at its Malaysian facility to the country’s Ministry of Health.
Biocon says it is well-positioned to up production of its Lantus biosimilar after the insulin glargine – co-developed with Mylan – was accepted for review in the EU.
Eli Lilly’ manufacturing network will give it the edge in the glargine insulin market, the firm says having received tentative approval of its “Lantus look-alike” from the USFDA.
With the EMA’s CHMP (Committee for Medicinal Products for Human use) recommending approval for a new insulin biosimilar early last month, some in the industry are expecting an increasingly competitive field moving forward.
The EU’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion and recommended granting a marketing authorisation to Boehringer Ingelheim and Eli Lilly’s biosimilar insulin treatment for Type 1 and Type 2 diabetes patients.
