Samsung Bioepis Co., Ltd.

Takeda's third-quarter pipeline cull, a head-to-head win against Novo Nordisk's semaglutide and a potential $1 billion-plus licensing deal by Roche made our news this week. Takeda tightened its pipeline in the third quarter. Innovent Biologics reported a head-to-head win against semaglutide in a Chinese phase 3 trial. Roche licensed a respiratory bispecific candidate in a potential $1 billion-plus deal. And more.1. Takeda drops AstraZeneca-partnered neurological program after phase 2 failureTakeda’s AstraZeneca-partnered alpha-synuclein antibody, TAK-341/MEDI1341, has failed in a phase 2 study in multiple system atrophy. The Japanese pharma also stopped developing the orexin-2 receptor agonist danavorexton (TAK-925) for narcolepsy “due to strategic considerations,” while phase 2 development in respiratory conditions remains ongoing.2. Innovent, Lilly's mazdutide trumps Novo's semaglutide in head-to-head diabetes, weight loss studyInnovent Biologics’ China-approved mazdutide has topped Novo Nordisk’s 1-mg semaglutide in a Chinese phase 3 trial conducted in patients with early-stage Type 2 diabetes and obesity. A 6-mg dose of the first-in-class GLP-1/glucagon dual receptor agonist outperformed semaglutide on the proportion of patients who met certain blood sugar and body weight benchmarks. The drug is partnered with Eli Lilly in the country.3. Roche pens $1B biobucks deal for Chinese company's respiratory disease bispecificRoche is paying $75 million upfront and committing up to $995 million in milestones to license a long-acting TSLPxIL-33 bispecific from China’s Qyuns Therapeutics. Coded QX031N, the drug holds promise for chronic obstructive pulmonary disease and asthma, according to Qyuns. The long-acting TSLP mechanism last year attracted GSK to a $1 billion buyout of Aiolos, which got its candidate from China’s Jiangsu Hengrui Pharma.4. Merck, Eisai scrap ambitions for Keytruda-Lenvima pairing in liver cancer subtype after survival missMerck & Co. and Eisai’s Keytruda and Lenvima failed to significantly extend patients’ lives when added to standard transarterial chemoembolization in unresectable, non-metastatic liver cancer. The overall survival miss at an interim analysis has led the pair to close the phase 3 Leap-012 trial. While an FDA expansion appears unlikely, the regimen was recently approved in China based on a positive progression-free survival readout.5. Boehringer returns to Kyowa Kirin with €640M pact for preclinical autoimmune moleculeIn a deal worth up to 640 million euros ($743 million), Boehringer Ingelheim has licensed a preclinical program from Kyowa Kirin that the German pharma hopes could become a “first-in-class … treatment of autoimmune diseases.” No details on the drug’s target or specific indications were given.6. WuXi AppTec sharpens focus by selling off China-based clinical research unitsWuXi AppTec is selling its China-based CRO WuXi Clinical and site management organization WuXi MedKey to Hillhouse. With the divestments, the company aims to emphasize its drug discovery, laboratory testing, process development and manufacturing services, according to a securities filing.7. BIO’s John Crowley urges ‘strategic action’ to strengthen FDA amid China’s biotech rise (Testimony before Congress)In a testimony before the Senate Health, Education, Labor, and Pensions Committee, Biotechnology Innovation Organization chief John Crowley called for “proactive, strategic action” to strengthen the FDA to secure “America’s biotech future” amid China’s rapid rise in biotech. His long list of recommendations includes reducing the time, cost and complexity of early drug development and improving the agency’s first-cycle review success rate.Other News of Note:8. Birds, lizards and cats, oh my: FDA blasts generic drug maker Hetero in scathing Form 4839. Roche's Chugai strikes $200M M&A deal to take over IgAN asset in several Asian countries10. Biogen boosts sales outlook on 'resilient' legacy MS franchise as new launches build momentum11. Astellas taps social media star Babs Costello to promote Izervay for geographic atrophy12. Samsung Bioepis gains full rights to Lucentis, Eylea biosimilars from Biogen in Europe (release)

INCHEON, Korea--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. announced today that the company has entered into an Asset Purchase Agreement (APA) with Biogen regarding Samsung Bioepis’ two ophthalmology assets: BYOOVIZ® (ranibizumab), a biosimilar referencing Lucentisi (ranibizumab) and OPUVIZ™ (aflibercept), a biosimilar referencing Eyleaii (aflibercept) — in Europe. Samsung Bioepis will have full responsibility for commercialization of BYOOVIZ upon the transfer of commercial rights from Biogen back to Samsung Bioepis, effective as of January 2026. We are pleased to announce our direct commercialization initiative for BYOOVIZ in Europe. We will work closely with Biogen to ensure a seamless transition and the continued delivery of services to our customers and patients in Europe. “We are pleased to announce our direct commercialization initiative for BYOOVIZ in Europe. We will work closely with Biogen to ensure a seamless transition and the continued delivery of services to our customers and patients in Europe,” said Linda Choi MacDonald, Executive Vice President and Global Head of Commercial, at Samsung Bioepis. “Samsung Bioepis will continue to broaden our reach to patients across Europe by reinforcing our leadership and expertise in biosimilars.” BYOOVIZ (ranibizumab) was approved by the European Commission (EC) in August 2021 as the first ophthalmology biosimilar in Europe for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), and Myopic Choroidal Neovascularization (mCNV). BYOOVIZ became commercially available in several countries within Europe from March 2023. OPUVIZ (aflibercept) was approved by the EC in November 2024 and by the Medicines and Healthcare products Regulatory Agency (MHRA) in April 2025 for the treatment of patients with Wet AMD, Visual Impairment due to Macular Oedema Secondary to RVO, Visual Impairment due to Diabetic Macular Edema (DME), and Visual Impairment due to mCNV. OPUVIZ will not be launched until after the lapse or revocation of relevant patent(s) for the reference biologic Eylea that also covers OPUVIZ in Europe. About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – LinkedIn, X. Lucentis is a trademark of Genentech, Inc. Eylea is a trademark of Bayer AG

Regeneron's agreement with Celltrion follows recent settlements with other Eylea biosimilar makers including Sandoz and Biocon Biologics. Regeneron has settled its patent dispute with Celltrion, giving the go-ahead for another biosimilar to its blockbuster eye drug Eylea (aflibercept) to hit the U.S. market in just over a year.The deal settles all patent litigation between the two companies and allows Celltrion to launch its biosimilar on Dec. 31, 2026, Regeneron said in an Oct. 20 statement. Other terms of the agreement, including financial considerations, remain confidential.South Korean drugmaker Celltrion won U.S. approval for its biosimilar on Oct. 9, with the FDA signing off on the drug's use in the same indications Eylea holds for neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy. The Eylea biosim will be marketed under the name Eydenzelt. In trials, the drug “met the predefined equivalence criteria” to Eylea and showed similar results to the reference product in secondary endpoints of efficacy, safety and immunogenicity, according to Celltrion.  Celltrion is the latest to win an FDA nod for its aflibercept product out of the biosim developers Regeneron has sued. Celltrion, Sandoz, Amgen, Formycon, Samsung Bioepis and Mylan Pharmaceuticals—plus partner Biocon Biologics—have all been the subjects of Regeneron’s attempts to block out the biosimilar competition in the courts.Only Amgen, however, has emerged with a legal victory over Regeneron, enabling the company to sell the only marketed Eylea biosimilar in the U.S. But, with Regeneron's recent settlements, the competition is poised to intensify next year.  Sandoz’s Enzeevu, for one, is allowed to launch in the fourth quarter of 2026, or earlier in “certain circumstances,” under that company's recent agreement with Regeneron. Enzeevu is an interchangeable biosimilar, meaning it can be substituted at the pharmacy counter without a new prescription from a doctor.Biocon and Mylan became the first to settle with Regeneron back in April, allowing their interchangeable Yesafili to launch in the second half of 2026. Regeneron is still blocking Samsung Bioepis’ Opuviz and Formycon’s Ahzantive biosimilars from launching and hasn’t given up on its dispute with Amgen, filing another complaint as recently as June. Eylea pulled down $1.1 billion in U.S. sales last quarter, a 25% fall from the same period last year.