Handok, Inc.

The regulatory filings for Bmab 1200 in certain markets are currently under review. Credit: Corona Borealis Studio/Shutterstock. Biocon Biologics has reached a settlement and licence agreement with Janssen Biotech, Janssen Sciences Ireland and Johnson & Johnson (collectively called Janssen) for the commercialisation of Bmab 1200 (bUstekinumab), a proposed biosimilar to Stelara (Ustekinumab). Biocon plans to commercialise the product in key markets such as Europe, the United Kingdom, Canada and Japan on receipt of regulatory approvals. The agreement resolves patent disputes between the parties and enables market entry for Biocon Biologics’ product in these regions. The regulatory filings for Bmab 1200 are currently under review. The development follows the company’s previous announcement of a settlement agreement in the US, which permits the launch of Bmab 1200 no later than 22 February 2025, pending approval from the US Food and Drug Administration (FDA). See Also: AstraZeneca may pull plug on UK vaccine manufacturing plans Ginkgo Bioworks gets grant for modified aav capsid proteins and virus vectors The FDA has accepted the company’s biologics licence application for Bmab 1200 under the 351(k) pathway. Stelara is a monoclonal antibody indicated to treat various immune-mediated ailments by targeting interleukin IL-12/23. It is approved for conditions such as psoriasis, Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. The reference brand, Stelara, reported global sales of $10.85bn in 2023. Biocon Biologics CEO and managing director Shreehas Tambe stated: “This settlement agreement is testament to our proven track record of science and innovation and is another key milestone in our journey to bring our biosimilar Bmab 1200 (bUstekinumab) to global markets. “Bmab 1200 will significantly strengthen our immunology franchise, enabling us to offer an affordable and effective treatment option for patients impacted by autoimmune diseases.” In May 2024, Biocon entered an exclusive licence and supply agreement with Handok to commercialise synthetic Liraglutide in South Korea.

Biocon will handle Liraglutide’s development, manufacturing and supply. Credit: Poetra.RH / Shutterstock.com. Indian biopharmaceutical company Biocon has entered an exclusive licence and supply agreement with Handok to commercialise synthetic Liraglutide in South Korea. A vertically integrated, complex drug, Liraglutide is administered using pre-filled injection pens. It is designed for chronic weight management alongside a reduced-calorie diet and increased physical activity. Biocon will handle Liraglutide’s development, manufacture and supply in South Korea. Handok will oversee the regulatory approvals and commercialisation of the product in the market. Handok’s diabetes care portfolio includes Amaryl, Tenelia and the real-time glucose monitoring device Barozen Fit. See Also: Alvotech and Dr Reddy’s partner to commercialise AVT03 (Cilostazol + rosuvastatin) by Korea United Pharm for Chronic Coronary Artery Disease (CAD) (Ischemic Heart Disease): Likelihood of Approval Global contract research organisation IQVIA ‘s moving annual total for the fourth quarter of 2023 values the market opportunity for Liraglutide in South Korea at $47m. Biocon CEO and MD Siddharth Mittal stated: “We are pleased to enter into this strategic partnership with Handok, which will enable patients in South Korea dealing with weight management to gain access to our GLP-1 peptide drug product, synthetic Liraglutide. “This also aligns with our commitment to expand our portfolio of innovative, affordable medicines to address the unmet needs of patients around the world. We look forward to leveraging Handok’s strong capabilities to help patients in the region better manage their disease.” In December 2023, Biocon’s subsidiary Biocon Biologics completed the integration of Viatris’ biosimilars business across 31 European countries.

PIVLAZ™ is the first drug approved in South Korea for the prevention of Cerebral Vasospasm in patients with Aneurysmal Subarachnoid Hemorrhage (aSAH) PIVLAZ™ will become commercially available in South Korea in early 2025 15 April 2024 – Nxera Pharma Co. Ltd (“Nxera” or “the Company; TSE 4565) – formerly known as Sosei Group or Sosei Heptares – today announces that its operating business Nxera Pharma Korea (“NPK”) has entered into an exclusive supply and distribution agreement with Handok Inc. (“Handok”) to commercialize PIVLAZ™ (clazosentan sodium) 150 mg in South Korea. Under the terms of the agreement, NPK will provide drug product to Handok at an agreed price and Handok is exclusively responsible for the promotion, marketing, sales and distribution of PIVLAZ™ in South Korea. Nxera will receive a one-off upfront payment from Handok upon signing of the agreement and is eligible for further commercial milestone payments plus sales coming from product supply. Handok is a leading innovation-driven pharmaceutical/healthcare company in South Korea. Handok has been a pioneer in the Korean pharmaceutical industry by introducing new products to the Korean market through partnerships, internal R&D, and state-of-the-art manufacturing while maintaining a global standard compliance program. PIVLAZ™ is approved in South Korea for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction, and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage (aSAH). Satoshi Tanaka, Dr Med Sci., Executive Officer and Executive Vice President of Nxera, Chairman of NPK, added: “We are pleased to be continuing our long-standing partnership with Handok to bring PIVLAZ™ to patients in South Korea. PIVLAZ™ represents a potentially life-changing treatment option for patients and Handok’s wealth of expertise and history of delivering products to the Korean market makes them the ideal partner. With this partnership in place, we are confident that we will be able to deliver PIVLAZ™ to physicians and patients in South Korea in early 2025.” Nxera Pharma (formerly Sosei Heptares) is a technology powered biopharma company, in pursuit of new specialty medicines to improve the lives of patients with unmet needs in Japan and globally. In addition to several products being commercialized in Japan, we are advancing an extensive pipeline of over 30 active programs from discovery through to late clinical stage internally and in partnership with leading pharma and biotech companies. This pipeline is focused on addressing major unmet needs in some of the fastest-growing areas of medicine across neurology, GI and immunology, metabolic disorders and rare diseases, and leverages the power of our unique and industry leading GPCR-targeted structure-based drug discovery “NxWaveTM” platform to provide a sustainable source of best- or first-in-class candidates. Nxera employs over 350 talented people at key locations in Tokyo and Osaka (Japan), London and Cambridge (UK), Basel (Switzerland) and Seoul (South Korea) and is listed on the Tokyo Stock Exchange (ticker: 4565). The content above comes from the network. if any infringement, please contact us to modify.