Friday, June 27, 2025

Teva's Ratiopharm Bags Rights In Germany To Formycon's Stelara Biosimilar

(6/27, Dean Rudge, Generics Bulletin) ...Teva's German subsidiary, Ratiopharm, is set to launch a biosimilar of Stelara, named Fymskina, in the third quarter of this year under a distribution agreement with Formycon for semi-exclusive commercialization rights..."We are delighted to have gained Teva/Ratiopharm as a strong second partner for the commercialization of FYB202 in our important home market Germany," commented Formycon... Global Sub. Full

GSK, Gilead, Novo Nordisk Join Other Big Pharmas in Honoring 2025 LGBTQ+ Pride Month

(6/26, Andrea Park, Fierce Pharma) ...A Fierce Pharma Marketing review of the LinkedIn and Instagram pages of the 20 largest pharmas found that, as of Thursday, with Pride Month nearing its end, the vast majority have acknowledged the celebration in some way...Almost half of the drugmakers did opt to add rainbow overlays or accents to their logos on social media this year, including Pfizer, Novartis, Eli Lilly, Sanofi, Takeda, Gilead Sciences, Bayer, Teva Pharmaceuticals and CSL. Many took the celebrations offline, too: CSL posted a video of its headquarters lit up in rainbow colors, Gilead raised the Pride flag at several of its campuses, Teva shared several photos of employees enjoying Pride-themed gatherings around the world and AstraZeneca's U.S. social media accounts showed employees attending Pride parades... Full

PBM Spread Pricing Ban & Related Reforms Struck From Reconciliation

(6/26, Gabrielle Wanneh, Inside Health Policy) ...A provision banning pharmacy benefit managers from charging health plans in Medicaid more for covered drugs than what they pay pharmacies to dispense those same treatments was snuffed out of the Senate Finance Committee's draft bill for budget reconciliation this week, but a coalition representing smaller, more transparent PBMs that already avoid this traditional PBM practice is optimistic the provision will make a comeback in separate legislation before the year's end or weave its way back into the reconciliation bill... Sub. Req’d

Biogen Escapes Class Action Over PBMs, Generic Drug Entry Plan

(6/26, Nyah Phengsitthy, Bloomberg Law) ...Biogen Inc. notched a win in a legal battle over whether it unlawfully orchestrated a scheme working with the nation's largest pharmacy benefit managers to impair competition from generic versions of its brand-name drug Tecfidera. Judge April Perry of the US District Court for the Northern District of Illinois tossed a class action by the city of Baltimore and sponsors of employee health plans on Wednesday because their allegations fail to adequately plead cognizable antitrust claims and lack directness between themselves and the injuries allegedly suffered... Sub. Req’d

Trump’s Threat of More Tariffs Makes US Trade Partners Wary of Signing Deals

(6/26, Malcolm Scott, Yoshiaki Nohara, Shruti Srivastava and Philip Heijmans, Bloomberg) ...Tariff negotiations with the Trump administration are running into roadblocks, as partners including Japan, India and the European Union balk at signing deals without knowing how badly they'll be hit by separate levies on exports including chips, drugs and steel... Sub. Req’d

Matsui and Crenshaw Introduce Bipartisan Bill to Prevent Drug Shortages by Addressing Vulnerabilities in the Pharmaceutical Supply Chain

(6/26, Congresswoman Doris Matsui) ...The MAPS Act would require the Department of Health and Human Services (HHS) to update its Essential Medicines List and create a map of the pharmaceutical supply chain. The map would include the country of origin, quantity manufactured, and other key information about critical drug products to identify supply chain weaknesses that could lead to shortages or other challenges in a future public health emergency. With this insight, HHS will be better equipped to predict disruptions, identify bottlenecks, and build resilience into the system—ultimately helping to prevent future public health emergencies... Full

New Report On Patent Litigation Settlements Says that they are Critically Necessary to Ensure Prompt Generic and Biosimilar Market Entry

(6/26, Kurt R. Karst, FDA Law Blog) ...The report, based on research and analysis undertaken by the IQVIA Institute for AAM, concludes "that patent settlements between brand and generic/biosimilar medicine manufacturers accelerated patient access to generic and biosimilar medicines to market by, on average, more than five years before patent expiration," and that there were significant healthcare system savings... Full

CVS Unit Ordered to Pay $95 Million in Medicare Whistleblower Lawsuit

(6/26, Jonathan Stempel, Reuters) ...Chief Judge Mitchell Goldberg in Philadelphia ordered the payment by CVS Caremark on Wednesday, following an eight-day non-jury trial in March in the whistleblower case. Goldberg will decide after further briefing whether to triple the award to $285 million under the federal False Claims Act...CVS, based in Woonsocket, Rhode Island, said on Thursday it was disappointed in the rulings against CVS Caremark... Full

Navitus Private-Label Ustekinumab Available July 1

(6/26, Stanton Mehr, Biosimilars Review & Report) ...Utilizing Alvotech/Teva's ustekinumab biosimilar, Navitus Health will begin offering its Lumicera Health branded ustekinumab-aekn, beginning July 1, while excluding the reference product Stelara. The net price of this product is said to be approximately $1,000 per 90-mg dose, or more than a 90% discount from Stelara's wholesale acquisition cost (WAC)... Full

Formycon Signs US-Canada Deal With Valorum Biologics For Eylea Biosimilar

(6/26, Urte Fultinaviciute, Generics Bulletin) ...Formycon has granted Valorum Biologics commercialization rights to its FYB203 (aflibercept-mrbb) biosimilar in the US and Canada. Under the deal, Formycon will earn a share of payment streams to Klinge Biopharma, which has exclusive global rights to the biosimilar. At the same time, Formycon announced an early closure for its bond offering due to high demand, indicating confidence in its business strategy and growth potential... Global Sub. Full

Biocon Biologics Gets Nod to Launch Eye Medicine, Yesafili in Canada

(6/27, Financial Express) ...On June 27, the company announced it has received the green light from Health Canada for its Yesafili in both vial and prefilled syringe forms. The injection is approved in the 2 mg/0.05 mL strength. Biocon Biologics confirmed that Canada will be the first country where Yesafili will be launched, with a rollout set for July 4, 2025. This marks the tenth biosimilar that Biocon Biologics is bringing to market globally... Full

Kashiv's Xolair Biosimilar Nears US And EU Filings As Phase III Data Reports

(6/27, Urte Fultinaviciute, Generics Bulletin) ...Kashiv's omalizumab candidate demonstrated therapeutic equivalence and comparable safety in a Phase III trial. Filings in the US and EU are expected to occur before the end of the year, as the UK MHRA already accepted the application for the product back in March. Competitors like Celltrion and Teva are also advancing their own omalizumab biosimilars. However, no launches are expected in the US until at least 2025, according to the originator... Global Sub. Full

Amgen Targets Hikma, Organon in Fresh Prolia, Xgeva Patent Suits

(6/26, Christopher Yasiejko, Bloomberg Law) ...Amgen Inc. filed lawsuits in New Jersey federal court separately accusing two pairs of companies of infringing more than two dozen patents each with proposed biosimilars of its Prolia and Xgeva bone drugs... Sub. Req’d

India's Biocon Drops Plan to Launch Weight-Loss Drugs in China, Executive Says

(6/27, Andrew Silver, Reuters) ..."We decided not to do it in China, not supply or register the product in China, either finished product or the API, because there is ample capacity and players available in China," Amit Kaptain, head of Biocon's commercial active pharmaceutical ingredients (API) business, told Reuters in Shanghai...Chinese drugmakers have rushed to develop generics or biosimilars as the patent for semaglutide, a key ingredient in both Ozempic and Wegovy, ends in early 2026 in China... Full

Novo Nordisk Says WeightWatchers Will Sell Wegovy, Announces $299 Price

(6/27, Amina Niasse, Mariam Sunny, Reuters) ...Under the deal, cash-paying patients can access a month's supply of Wegovy through the Danish drugmaker's Novocare pharmacy for $299. The one-time price will also be available through Novo's other telehealth partners through July 31, the company said in a release...Novo said it is maintaining deals with Ro and LifeMD, rivals to WeightWatchers... Full

Novartis Pens ProFound Pact, Offering Up $750M Biobucks Per Cardiovascular Target

(6/26, Gabrielle Masson, Fierce Biotech) ...Novartis will work with the Flagship Pioneering–founded biotech to develop first-in-class medicines across a range of cardiovascular diseases. The companies did not disclose how many possible targets are included in the deal terms. The pair will use ProFound's protein detection platform to identify and validate new proteins within the expanded human proteome for possible therapeutic development... Full

Gilead Stops RSV Antiviral Trials After Low Incidence Rates During Recent Season

(6/26, Kyle LaHucik, Endpoints News) ...The move was the result of "lower than expected RSV incidence rates during the most recent RSV season in the Northern Hemisphere," a Gilead spokesperson said in an emailed statement to Endpoints News on Thursday afternoon. The low rates made it "difficult to determine meaningful rates of symptom reduction, a primary endpoint of the study," the spokesperson said. The decision wasn't related to safety or efficacy concerns, they added... Sub. Req’d

CDC Immunization Advisory Panel Endorses Merck's New RSV Shot, But Not Without Dissent

(6/26, Kevin Dunleavy, Fierce Pharma) ...The ACIP signed off on recommending Merck's newly approved monoclonal antibody by a vote of 5 to 2. The committee endorses one dose of Enflonsia to be given to infants younger than 8 months of age who are born during or entering their first RSV season and who are not already protected by a maternal vaccine... Full

Kiran Mazumdar-Shaw On AI, Biosimilars & Funding India's Biotech Future

(6/27, Palak Agarwal, Business Today) ...In a conversation with Business Today, Dr. Kiran Mazumdar-Shaw highlighted the evolving India-U.S. collaboration in biopharma, with a special focus on the role of AI and the growing potential of biosimilars. She also stressed the need for greater public capital to support the growth of biotech startups in India... Full

Thousands May Be Affected by Defective Pills Sold by N.J.-Based Drug Maker, Lawsuit Says

(6/27, Colleen Murphy, NJ.com) ...The lawsuit, filed in federal court in Newark, accuses Glenmark Pharmaceuticals Inc., USA—headquartered in Mahwah—of selling defective potassium chloride capsules that failed to dissolve properly in the body. Glenmark issued a nationwide recall of 114 batches of the capsules on or around June 25, 2024, after the U.S. Food and Drug Administration flagged the product for failing dissolution tests... Full

Why Can't the US Figure Out Weight Loss Drug Prices?

(6/27, Robert Barrie, Pharmaceutical Technology) ...It remains to be seen if the pricing of compounded GLP-1RAs remains stable going forward, and indeed if the FDA will allow telehealth companies to continue offering the medication under personalised therapies. Ultimately, the market will be swayed by patient demand, which can easily change... Full

Repurposed Drugs: EU Pharma Reform Offers Boost, But Payers ‘Must Recognize Health Gains'

(6/26, Eliza Slawther, Pink Sheet) ...The EU has suggested introducing a four-year data protection period for certain repurposed medicines, a move that has been praised by industry. Raluca Radu of Medicines for Europe emphasized the importance of broader recognition of all types of repurposed medicines to maximize patient benefits. Concerns were raised regarding pricing parity with generics, which may undermine the economic viability of new formulations... Global Sub. Full

Denmark Introduces First Confidential Pricing Framework For Primary Care Medicines

(6/26, Francesca Bruce, Pink Sheet) ...For the first time in Denmark, pharmaceutical companies will be able to negotiate confidential prices for some primary care medicines, which are prescribed in general practice settings. The move will mean increased sales for products with high prices that would otherwise exclude them from reimbursement and also allow companies to protect their Danish drug prices from reference pricing... Global Sub. Full

Canada Unveils Draft List of Essential Drugs For Universal Pharmacare

(6/26, Neena Brizomohun, Pink Sheet) ...Canada's Drug Agency is working on developing a national formulary and has proposed an initial list of essential prescription drugs that should be included or excluded. Drug companies and other pharmaceutical stakeholders have until July 18 to comment on the list. The agency is planning to launch a separate public consultation next month on options for a national bulk purchasing strategy for federal, provincial and territorial governments... Global Sub. Full

Britain's Biggest Drug Maker Defies Trump to Bet On Beijing

(6/27, Hannah Boland, The Telegraph) ...With Donald Trump and Xi Jinping firing shots at each other in an ever--escalating trade row, it was presumed that the AstraZeneca boss would want to keep his head down. Yet, Sir Pascal was happy to make his position clear: "The two large innovators in our industry today are the US and China," the no-nonsense Frenchman said on the sidelines of the forum, and China was posied to "emerge as really a driving force for innovation in our sector"... Full

Why More Indians Are Ditching Costly Medicines - And Trusting Generics

(6/27, Durgesh Nandan Jha, The Times Of India) ...Generic drugs were received poorly when the Jan Aushadhi scheme was launched in 2008, but people's outlook towards it is changing, slowly. This is also reected in govt data... Full

Despite Increased Scrutiny, Indian Exports to US to Maintain Growth Trajectory, Says CareEdge Ratings

(6/26, Pharmabiz.com) ...Despite more US Food and Drug Administration (FDA)-approved facilities and increased inspections, Official Action Indicated (OAI) observations stayed around 7%, down from 15-20% between calendar year (CY) 2013 and CY17. This highlights improved compliance with cGMP by Indian pharma companies standards, said the company in its latest report on US FDA Inspections in India. The report said that Indian pharma is at the crossroads of opportunity and responsibility, amidst the increasing inspections... Full

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