Clinical Trials
58
2 active
Approvals
20
Total approvals
Agencies
4
Regulatory bodies
Founded
N/A
Completed
39
67.2%
Not yet recruiting
2
3.5%
Recruiting
6
10.3%
Terminated
2
3.5%
Unknown
8
13.8%
Withdrawn
1
1.7%
- Biocon received MHRA approval for a new drug product fill-finish unit for Semglee (insulin glargine) at its insulin manufacturing facility in Malaysia. - The UK clearance, announced on September 25, 2026, follows EMA approval of the same fill-finish line in July 2026, a two-month regulatory sequence. - The approval validates the Malaysian plant's operational readiness for commercial production and expands Biocon's supply chain capacity for diabetes care products. - Biocon also holds a CHMP positive opinion for its pertuzumab biosimilar Pebrilzo, the first monoclonal antibody biosimilar reviewed under the EMA's tailored clinical development approach.
- Biocon Limited has signed a 10-year supply contract for Pertuzumab in Brazil through a partnership with Bahiafarma and Bionovis. - The consortium received 100% allocation under Brazil's Productive Development Partnership (PDP) programme, granting exclusive access to the public healthcare market covering roughly 70% of demand. - Pertuzumab, a monoclonal antibody for HER2-positive breast cancer, is not currently manufactured locally and represents significant expenditure for Brazil's Unified Health System (SUS). - The agreement includes milestone payments, revenue sharing, and phased localisation of production to expand access and build local manufacturing capabilities.
- Biocon has received marketing approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for its pegfilgrastim biosimilar, confirmed on August 25, 2026. - The product, developed and manufactured by wholly-owned subsidiary Biocon Biologics Ltd., serves as a biosimilar to Neulasta®, a registered trademark of Amgen Inc. - Sandoz K.K. will exclusively promote, sell, and distribute the pegfilgrastim biosimilar in Japan, with Global Regulatory Partners Japan acting as Marketing Authorization Holder. - The approval strengthens Biocon's biosimilar portfolio in one of Asia's largest pharmaceutical markets and reaffirms its commitment to increasing patient access to affordable medications.
- Biocon's partner Duopharma Biotech secured multiple insulin contracts from Malaysia's Ministry of Health valued at over MYR 225 million. - The contracts cover short-acting recombinant human insulin, insulin glargine, and insulin aspart, with agreements spanning two to three years. - Biocon's Johor facility, Asia's largest integrated insulin manufacturing plant, will supply the products, supporting over 450,000 patients in Malaysia's public healthcare system. - An estimated 4.75 million people live with diabetes in Malaysia, underscoring the critical need for affordable and accessible insulin therapies.
- Biocon Academy celebrated its 10th Graduation Ceremony in Bengaluru, graduating 156 students across five specialized biosciences programs. - Women represented 70% of the graduating cohort, and seven top-performing students received Gold Medals for Academic Excellence. - The Academy has trained over 1,300 students since 2013 through industry-aligned programs bridging the gap between academia and the biopharmaceutical sector. - New programs in Artificial Intelligence in Life Sciences and Drug Metabolism and Pharmacokinetics were announced to align curriculum with emerging industry needs.
- Biocon Limited has appointed Shreehas Tambe as Chief Executive Officer and Managing Director effective April 1, 2026, following the integration of Biocon Biologics as a wholly owned subsidiary. - The leadership transition includes the resignation of current CEO Siddharth Mittal and CFO Mukesh Kamath, with Kedar Upadhye taking over as the new Chief Financial Officer. - Under Tambe's leadership at Biocon Biologics, the company emerged as one of the world's top five biosimilar companies with a valuation of USD 5.5 billion in 2025. - The restructuring creates a unified corporate structure combining biosimilars and generics businesses, positioning the company to compete effectively in diabetes, obesity, oncology, and immunology markets.
- Biocon Limited successfully completed a comprehensive 10-day FDA Pre-License Inspection at its Bengaluru biosimilars manufacturing facility from April 20-29, 2026. - The FDA issued five procedural observations in Form 483, with no critical findings related to data integrity or quality oversight systems. - The company plans to submit a Corrective and Preventive Action plan within FDA timelines to address all observations. - This regulatory milestone represents a significant step toward U.S. market approval for Biocon's biosimilar products.
- Biocon Limited announced the launch of its GLP-1 peptide liraglutide in the Netherlands through distribution partner Pharmamedic B.V., marking the first EU country where the company will directly market the drug under its own brand. - The drug-device combination will be marketed as Diavorin for diabetes treatment and Vobexoryn for chronic weight management, following approval from the Netherlands Medicines Evaluation Board earlier this year. - This launch represents a significant milestone in Biocon's strategy to expand its GLP-1 portfolio globally and deliver affordable metabolic treatments through its vertically integrated manufacturing capabilities. - The move reinforces the strategic importance of peptide-based therapies in Biocon's portfolio and demonstrates the company's commitment to broadening access to advanced diabetes and obesity treatments.
- Viatris has entered into definitive agreements to sell its entire equity stake in Biocon Biologics to Biocon Limited for $815 million, comprising $400 million in cash and $415 million in newly issued Biocon equity shares. - The transaction accelerates the expiration of biosimilars non-compete restrictions, allowing Viatris immediate access to ex-U.S. biosimilars markets upon closing and U.S. market access by November 2026. - The deal is expected to close in Q1 2026 and represents a strategic shift for Viatris to regain optionality in building its portfolio of generics, established brands, and innovative therapies.
- Biocon Limited has opened its first FDA-approved manufacturing facility in Cranbury, New Jersey, through its subsidiary Biocon Generics Inc, marking a significant milestone in the company's global expansion strategy. - The company invested over $30 million to establish the state-of-the-art oral solid dosage facility with an annual production capacity of 2 billion tablets after acquiring it from Eywa Pharma Inc. in 2023. - The facility enables Biocon to deliver vertically integrated, high-quality medicines more efficiently to US patients while strengthening supply chain resilience and accelerating global market expansion. - New Jersey Governor Phil Murphy attended the inauguration, highlighting the facility's role in fostering innovation, creating job opportunities, and strengthening the US healthcare ecosystem.
