Biocon Ltd. | MedPath

Malaysia Extends Biocon Biologics' Insulin Supply Contract for Six Additional Months

4 days ago

• The Malaysian Health Ministry has extended its insulin supply contract with Biocon Biologics for an additional six months, from April 29 to October 28, 2025, continuing a partnership that has lasted nearly a decade. • The extension follows the original three-year contract valued at $90 million awarded in 2022 for Biocon's recombinant human insulin brand Insugen, which is manufactured in Malaysia and distributed through local partner Duopharma Marketing. • Biocon's insulin products are available to patients across all Ministry of Health hospitals, district health offices, and health clinics throughout Malaysia, supporting the country's healthcare infrastructure.

Biocon Biologics Receives Positive CHMP Opinions for Denosumab Biosimilars in Europe

a month ago

• The Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Biocon Biologics' denosumab biosimilars, Vevzuo and Denosumab BBL, for bone health indications in Europe. • The positive opinions follow comprehensive data reviews demonstrating comparability with the reference product in pharmacokinetic, safety, efficacy, and immunogenicity profiles. • The European Commission will now review these recommendations before granting marketing authorizations, after which detailed information on approved indications will be published in official EU documentation.

Trump's Executive Order Delays Medicare Drug Price Negotiations, Sparking Industry and Policy Debate

a month ago

• President Trump signed an executive order extending the exemption period for small-molecule drugs from Medicare price negotiations by four years, a move criticized by advocacy groups as favoring pharmaceutical industry interests. • The order aims to address what the administration calls the "pill penalty" - the current policy where small-molecule drugs (90% of medications) face negotiations after 9 years while biologics have longer exemption periods. • The Medicare Drug Price Negotiation Program, established under the Biden administration, had already achieved price reductions of 38-79% on 10 high-cost drugs with projected savings of $6 billion if applied in 2023.

Biocon Biologics Secures Settlement with Regeneron to Launch Aflibercept Biosimilar in US by 2026

a month ago

• Biocon Biologics has reached a settlement agreement with Regeneron allowing the launch of Yesafili, an interchangeable biosimilar to aflibercept, in the US by the second half of 2026 or earlier under certain circumstances. • The agreement resolves pending legal disputes, including an appeal at the US Court of Appeals for the Federal Circuit and litigation in the Northern District of West Virginia, clearing regulatory hurdles for market entry. • FDA-approved in May 2024, Yesafili will target multiple ophthalmic conditions including neovascular AMD, macular edema due to retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization.

FDA Approves Biocon Biologics' Bevacizumab Biosimilar JOBEVNE for Multiple Cancer Indications

2 months ago

• Biocon Biologics has received U.S. FDA approval for JOBEVNE (bevacizumab-nwgd), a biosimilar to Avastin, expanding its oncology portfolio to include a seventh FDA-approved biosimilar. • JOBEVNE, a VEGF inhibitor that restricts tumor blood supply, is indicated for multiple cancer types including metastatic colorectal cancer, non-small cell lung cancer, glioblastoma, and several others. • The approval follows comprehensive comparative studies confirming JOBEVNE's similarity to Avastin, with U.S. bevacizumab sales reaching approximately $2 billion in 2023, representing a significant market opportunity.

Lilly's Mounjaro Demonstrates Superior Efficacy in Head-to-Head Trials Against Diabetes Competitors

2 months ago

• Eli Lilly's Mounjaro (tirzepatide) has shown superior efficacy in reducing HbA1c levels and body weight compared to Novo Nordisk's Ozempic in clinical trials, offering new hope for the 35 million Americans with type 2 diabetes. • As the first dual-action medication that stimulates both GLP-1 and GIP receptors, Mounjaro achieved mean HbA1c reductions of 1.7% to 2.4% across trials, with participants losing between 12-25 pounds depending on dosage. • Recently launched in India following CDSCO approval, Mounjaro is now indicated for both chronic weight management in adults with obesity or overweight with comorbidities, and as an adjunct treatment for type 2 diabetes mellitus.

Biocon Biologics and Civica Partner to Increase Affordable Insulin Aspart Access in US Market

3 months ago

• Biocon Biologics will supply Insulin Aspart drug substance to Civica, who will manufacture the final product at their Virginia facility to increase accessibility in the United States. • The partnership aims to address a critical healthcare need, as one in five diabetes patients has rationed insulin due to cost concerns, in a country where 38.4 million people live with diabetes. • The collaboration runs parallel to Biocon Biologics' own Insulin Aspart product currently under FDA review, demonstrating the company's multi-pronged approach to expanding insulin accessibility.

FDA Grants Priority Review to CUTX-101 for Menkes Disease, Offering Hope for Rare Pediatric Condition

5 months ago

• The FDA has accepted Sentynl Therapeutics' NDA for CUTX-101, granting priority review for the treatment of Menkes disease, a rare genetic disorder. • Clinical trials of CUTX-101 demonstrated an almost 80% reduction in mortality risk compared to untreated patients, significantly improving overall survival. • CUTX-101 has been granted multiple designations, including Breakthrough Therapy and Orphan Drug, highlighting its potential to address a critical unmet need. • Cyprium Therapeutics is eligible to receive up to $129 million in milestone payments and royalties, retaining ownership of a potential Priority Review Voucher.

FDA Approves Steqeyma and Yesintek: Expanding Biosimilar Options for Stelara

6 months ago

• The FDA has approved Steqeyma (ustekinumab-stba) and Yesintek (ustekinumab-kfce) as biosimilars to Stelara, offering new options for patients with autoimmune and inflammatory conditions. • Steqeyma and Yesintek are approved for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, mirroring Stelara's indications. • These approvals are expected to increase market competition and reduce treatment costs, with launches anticipated in early 2025 following licensing agreements.