In a significant development that has sent shockwaves through the biotechnology industry, Biocon Ltd. has come under fire from the U.S. Food and Drug Administration (USFDA) for compliance lapses at its Active Pharmaceutical Ingredient (API) facility in Bengaluru. The regulatory body identified four critical observations after conducting a stringent surveillance inspection at the facility between […]
Biocon Limited, the innovation-driven global biopharmaceutical frontrunner, has made headlines by sealing a significant partnership agreement with Juno Pharmaceuticals, Canada’s esteemed specialty pharmaceutical giant. This collaboration aims at the commercialization of Liraglutide, a sophisticated drug-device formulation. This game-changing combination has been curated for the proficient treatment and management of challenges like Type 2 diabetes and […]
Biocon Limited, a global leader in the biopharmaceutical industry, has made a landmark announcement: its wholly-owned subsidiary, Biocon Generics Inc., has successfully acquired Eywa Pharma Inc.’s oral solid dosage manufacturing facility. Located in Cranbury, New Jersey, the acquisition became effective on September 1, 2023, with a total transaction value of $7.7 million. This marks Biocon […]
Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd, has announced the successful integration of the acquired biosimilars business from Viatris in over 70 countries in emerging markets, effective from July 1, 2023. The integration represents an increase in the scale and scope of Biocon Biologics’ operations. This transition comes after the $3.3 billion deal […]
In a significant development for healthcare accessibility, Biocon Biologics Ltd (BBL), a subsidiary of Biocon, announced the availability of its biosimilar injection, HULIO (adalimumab-fkjp), in the US market. Already successful in Europe and Canada, HULIO provides an affordable, comparable alternative to the widely-used Humira (adalimumab). This landmark announcement comes shortly after Biocon Biologics’ $3.3 billion […]
Biocon Limited, an Indian biopharma company, said that its subsidiary Biocon Biologics has been issued a complete response letter (CRL) from the US Food and Drug Administration (FDA) for the biologics license application (BLA) for the Insulin-R product. The FDA has rejected the BLA seeking more data to support its submission and an expectation of […]
Biocon said that its subsidiary Biocon Biologics has wrapped up the previously announced $3.3 billion acquisition of the biosimilars business of US-based pharma company Viatris. The deal, which was announced in February 2022, closed after Biocon Biologics and Viatris secured all the required approvals from major global regulators such as the US Federal Trade Commission […]
Biocon Limited has entered into a semi-exclusive partnership with Zentiva, a Czech pharma company for marketing its drug-device combination Liraglutide for the treatment and management of Type 2 diabetes as well as obesity. As per the terms of the agreement, the Indian pharma company will handle Liraglutide’s manufacturing and supply to Zentiva for the commercialization […]
Biocon Ltd. said that its subsidiary Biocon Biologics has signed an out-licensing agreement with Japanese pharma company Yoshindo Inc. for commercializing a couple of its pipeline biosimilar assets — bDenosumab and bUstekinumab in Japan. Ustekinumab is a biosimilar of the reference drug Stelara, which is a monoclonal antibody for the treatment of psoriasis, ulcerative colitis, […]
Biocon Q4FY22 results : Biocon Ltd has reported a net profit of INR 239 crores for the fourth quarter of the fiscal year 2022 (Q4FY22), a 6% decrease, compared to a net profit of INR 253 crores in the same period of the previous fiscal year. The Indian biopharma company earned total revenue of INR […]