Friday, July 10, 2026

 

 

Teva Secures Exclusive Rights to Polpharma's Multiple Sclerosis Biosimilar

(7/9, Adriano Marchese, Dow Jones Newswires) ...The biopharmaceutical company said Thursday that the licensing agreement is for a biosimilar version of Ocrevus, or ocrelizumab, a medication used to treat multiple sclerosis. Under the terms of the agreement, Polpharma Biologics will retain full responsibility for the development and manufacturing of the biosimilar candidate. Teva will be responsible for regulatory submissions and commercialization of the intravenous and subcutaneous formulations in the U.S., Europe, Brazil, Canada, Australia, New Zealand, Israel and Turkey once it is approved... Sub. Req'd

 

Teva, Polpharma Ink Licensing Pact for Biosimilar Targeting Roche's Ocrevus

Dulan Lokuwithana

7/9, Seeking Alpha

Seeking Alpha

 

Teva and Polpharma Biologics Sign Global Deal for Ocrelizumab Biosimilar

(7/10, Salong Debbarma, Pharmaceutical Technology) ...The arrangement covers markets, including Australia, Canada, Brazil, Europe, Israel, New Zealand, Turkey, and the US... Full

 

What the Ocrelizumab Deal Does for the Multiple Sclerosis Biosimilar Pipeline

Zachary Zubulake

7/9, PharmTech

PharmTech

 

Teva and Polpharma Biologics Ink Global Biosimilar Agreement

(7/9, Charlie Sternberg, Contract Pharma) ..."This agreement is aligned with Teva's Pivot to Growth strategy and our focus on expanding our biosimilars pipeline. With our global commercial footprint and deep expertise in complex medicines, we are well positioned to help bring this biosimilar candidate to patients," said Yolanda Tibbe, Vice President, Global Head of Biosimilars at Teva... Full

 

Pharma M&A Roundup: Chemomab Therapeutics Enters Merger Agreement with Scipher Medicine, Teva and Polpharma Biologics Enter Global Licensing Agreement

Nicholas Jacobus

7/9, PharmExec.com

PharmExec.com

 

Samsung Bioepis Partners with Teva for OPUVIZ® in Canada

(7/10, Choi Mun-hee, BusinessKorea) ..."This agreement is an important step in strengthening our biosimilars portfolio in Canada," said Fabien Paquette, General Manager, Teva Canada. "It continues to build on our momentum in biosimilars, to expand our ophthalmology footprint, and reflects our commitment to bringing high-quality treatment options to Canadian patients and healthcare professionals through strategic partnerships."... Full

 

Teva Gives Samsung Bioepis Canadian Path For Aflibercept

(7/10, Dean Rudge, Generics Bulletin) ...Under the firms' license and commercialization agreement, Samsung Bioepis will remain responsible for registration and manufacturing, while Teva's Canadian subsidiary will take responsibility for commercialization...Financial terms of the agreement were not disclosed. Teva Canada said further details on the anticipated Canadian market launch of Opuviz would be provided "at the appropriate time."... Global Sub. Full

 

 

FDA Moves to Expose Hidden Foreign Drug Factories, Strengthen Domestic Production in Sweeping Rule Proposal

(7/10, Anders Hagstrom, Preston Mizell, FOX Business) ...The FDA is launching a new website to go along with the overhaul that details all the ways the agency can assist U.S. manufacturers. A major loophole the changes look to solve is foreign factories producing raw drug materials that stay completely invisible to the U.S. by routing the products through intermediate facilities overseas... Full

 

Clinical Data The Latest Front As Congress Moves To Counter China's Growing Pharma Clout

(7/9, Maaisha Osman, Pink Sheet) ...House appropriators are pushing to limit US Food and Drug Administration's ability to accept clinical trial data generated in China, Russia, Iran, and North Korea, the latest sign of mounting Capitol Hill concern over China's rise in the pharmaceutical sector. Taken alongside the BIOSECURE Act, the recently introduced Biotech Investment National Security Act, and the FDA's own push to streamline domestic investigational new drug (IND) review, the provision reflects a coordinated effort to reshape where, and with whom, the US pharmaceutical industry does its science... Global Sub. Full

 

FDA Hiring Numbers Show Failure To Meet PDUFA, BsUFA Goals

(7/9, Jessica Karins, Inside Health Policy) ...FDA updated its website Thursday (July 9) on the hiring commitments FDA made under the latest reauthorizations of the Prescription Drug User Fee Act (PDUFA VII) and the Biosimilar User Fee Act (BsUFA III). The agreements for those reauthorizations included hiring goals from fiscal 2023 and fiscal 2027. According to the tables on FDA's website, the agency has made no progress toward its hiring goals for fiscal 2026 and is now below the number of staff it was set to add under the agreements in fiscal 2023... Sub. Req'd

 

The Supreme Court Protected Generics. Now FDA Must Navigate The Aftermath

(7/9, Paul R. Gugliuzza and Jacob S. Sherkow, Health Affairs) ...The Hikma ruling should make timely generic entry more likely, with savings for patients and public payers. To avoid the threat of inducement liability, generic companies will not need to delay launch until method-of-use patents expire, avoid products with multiple indications, or settle patent disputes rather than relying on skinny labels... Full

 

National Priority Voucher Critics Ask Why The US FDA Needs Another Expedited Review Pathway

(7/9, Maaisha Osman, Pink Sheet) ...Critics questioned why the US Food and Drug Administration needs the National Priority Voucher program when it already has the fast track, breakthrough therapy, accelerated approval, and priority review pathways... Global Sub. Full

 

U.S. Supreme Court Weighs Inducement Liability Beyond FDA Carve-Out Labels

(7/10, Jeremy Lowe, PharmExec.com) ...The issue is not whether a generic may use a section viii carve-out. It may. The harder question is whether FDA-compliant carve-out labeling can still support inducement when paired with public statements, sales materials, website language, or investor communications that allegedly steer physicians back to the patented use... Full

 

The LOE Cliff

(7/9, Ryan Finn, Managed Healthcare Executive) ...Alex Keeton, M.P.P., executive director of The Biosimilars Council, a trade group for biosimilar makers, said in an email to Managed Healthcare Executive (MHE) that biosimilars have worked to deliver more than $56 billion in savings in just over a decade. But there are no biosimilars under development for 90% of the biologics expected to lose exclusivity in the next 10 years. according to Keeton. His organization wants Congress to pass several pieces of legislation to "remove unnecessary roadblocks, foster competition, and unlock the full promise of a sustainable biosimilars market," including the Biosimilar Red Tape Elimination Act, the ETHIC Act, and the Skinny Labels, Big Savings Act... Full

 

Report Projects High HIV Rates, Medicare Drug Costs By 2036

(7/9, Lauren Brensel, Inside Health Policy) ...The study, published Tuesday (July 7) in JAMA Network Open, projects that by the year 2036, there will be more than 71,000 new HIV cases in adults over 65. Medicare is expected to spend $187.2 billion over the decade treating them, with more than half of those costs associated with prescription treatments... Sub. Req'd

 

Maryland Coalition Highlights Prescription Drug Affordability

(7/9, Haley Rae, WMDT) ...Beginning Jan. 1, 2027, state and local governments could save millions of dollars on medications such as Ozempic and Jardiance through Maryland's Prescription Drug Affordability Board. Coalition President Vincent DeMarco said he hopes the board will eventually expand upper payment limits to additional high-cost prescription drugs... Full

 

 

Teva Submits FDA Application for Paediatric Tourette Syndrome Therapy

(7/10, PMLiVE) ...The submission is supported by phase 3 data recently published in JAMA Neurology. The study found that ecopipam significantly delayed time to relapse compared with placebo in children and adolescents who had responded to treatment during an earlier open-label phase... Full

 

Roche Ends 2 Huntington's Disease Programs, Including Ionis-Partnered Tominersen

(7/10, Darren Incorvaia, Fierce Biotech) ...The Swiss drugmaker explained its reasoning in a July 9 letter to the patient community..."We have made the difficult decision to discontinue both clinical development program," Mai-Lise Nguyen, patient partnership leader at Roche, wrote in the letter. The tominersen trial did not meet its efficacy objective, while RG6496's study was stopped based on results from a separate animal study... Full

 

 

Rituximab Noninferior to Ocrelizumab in Newly Diagnosed Relapsing MS, Head-to-Head Trial Finds

(7/9, Marco Meglio, NeurologyLive) ...Randomization favored rituximab 3:2 using 1000 mg then 500 mg q6mo versus ocrelizumab 600 mg q6mo in newly diagnosed, EDSS 0-4, DMT-naïve patients... Full

 

Pegfilgrastim Biosimilar Ennumo Gets FDA Approval

(7/9, Jaymin Kang, PharmD, MPR) ...Ennumo is supplied as a 6mg/0.6mL single-dose prefilled syringe for subcutaneous injection... Full

 

Biocon Announces Publication of Pivotal Clinical Data Supporting Effectiveness of Yesafili™, a Biosimilar to Eylea® (Aflibercept)

(7/9, Biocon Limited) ...The clinical data from the Phase III INSIGHT program evaluating MYL-1701P, its aflibercept biosimilar, was published in two peer-reviewed journals, contributing to the clinical evidence base supporting the development of aflibercept MYL-1701P for the treatment of diabetic macular edema (DME). MYL-1701P was approved and the vial format was granted interchangeable designation under the name Yesafili™ by the U.S. Food and Drug Administration in May 2024... Full

 

Celltrion's High-Margin Biosimilars Gain Ground Across Europe, Strengthening H2 Growth Outlook

(7/10, Lee Han-soo, Korea Biomedical Review) ...The product has shown particularly strong performance in Spain, one of the five major European markets (EU5), where it achieved a market share of about 71 percent, becoming the leading omalizumab therapy just six months after launch. Omlyclo has also expanded rapidly in other European countries, reaching 47 percent in Portugal, 41 percent in Ireland, and 31 percent in Norway... Full

 

Most Of Amgen's Counterattack Crumbles In Aflibercept Biosimilar Litigation

(7/9, Dean Rudge, Generics Bulletin) ...Amgen has lost most of the defenses and counterclaims it deployed against Regeneron in litigation over its Pavblu (aflibercept-ayyh) 2mg biosimilar to Eylea, after a federal district court in West Virginia overseeing the dispute struck out its fraud-based, antitrust and patent-misuse theories... Global Sub. Full

 

Actavis Dodges Some Claims in Skincare Drug Price-Fixing Lawsuit

(7/9, Katie Arcieri, Bloomberg Law) ...A reasonable jury could find that Actavis "more likely than not" conspired to avoid competing with drugmaker Sandoz in the Ciclopirox shampoo market, Judge Michael P. Shea of the US District Court for the District of Connecticut said in a Wednesday order partly granting and partly denying Actavis' motion for summary judgment... Full

 

How Unclaimed Patent Disclosures Are Becoming Generics' Hottest New Defense

(7/10, Dean Rudge, Generics Bulletin) ...In an exclusive interview with Generics Bulletin, Katten attorneys Deepro Mukerjee and Lance Soderstrom explain how Mylan's epoprostenol Federal Circuit win may reshape patent-disclosure and equivalence strategies in ANDA litigation... Global Sub. Full

 

 

India's Dr Reddy's Set for Worst Week in 3 Years as Semaglutide Setback Fuels Growth Concerns

(7/10, Kashish Tandon, Reuters) ...The company said supplies of its generic semaglutide would remain unavailable in India and face disruptions in Canada until at least late October, after an impurity issue in the drug's active ingredient halted production of new batches. BofA analysts said the timing of supply resumption would be critical, warning the setback could prevent Dr Reddy's from capturing high-value volumes during a limited-competition period in Canada... Full

 

U.S. Biotechs Are Keeping More Secrets to Beat Copycats in China

(7/9, Xavier Martinez, The Wall Street Journal) ...Today, when a drug company publishes a successful clinical trial at a major medical conference, it runs the risk that a firm in China will replicate their work, launching competing clinical trials using the same science... Sub. Req'd

 

 

Poland's Prescription Reform Sparks Rollout Warning From Industry

(7/10, Paulina Mozolewska, Euractiv) ..."The same objectives could be achieved through the existing e-prescription system without creating additional burdens for patients," Krzysztof Kopec, president of the Polish Association of Pharmaceutical Industry Employers - National Drug Producers (NPP), told Euractiv... Full

 

UK Minister Defends US Pharma Deal Following Calls to Scrap It

(7/10, Ashleigh Furlong, Bloomberg) ...A trade deal with the US that increases the price Britain pays for new medicines will help patients and not cause hundreds of thousands of additional deaths, according to UK Technology Secretary Liz Kendall... Sub. Req'd

 

UK Pharmacies Report High Demand as Weight-Loss Pills Go on Sale

(7/10, Laura Hughes, Aanu Adeoye and Madeleine Speed, Financial Times) ...A survey by the National Pharmacy Association found 70.6 per cent had received enquiries from patients looking to start treatment on weight-loss pill Wegovy, which has been available to buy from high street pharmacies and online providers since Monday... Sub. Req'd

 

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