Friday, February 21, 2025

Teva Pharma and Alvotech Launch US Biosimilar to J&J's Stelara

(2/21, Kamal Choudhury, Reuters) ...Teva Pharmaceuticals and Alvotech said on Friday they have launched a biosimilar to Johnson & Johnson's autoimmune drug Stelara in the United States, the second in a wave of near-copies of the blockbuster treatment...Selarsdi has been launched in Canada as Jamteki, in Europe as Uzpruvo, and in Japan as Ustekinumab BS... Full

Alvotech Eyeing US Aflibercept Biosimilar Approval This Year With FDA Acceptance

(2/20, Dean Rudge, Generics Bulletin) ...The study met its primary endpoint, with results demonstrating therapeutic equivalence and comparable safety including immunogenicity between Alvotech's biosimilar candidate and Eylea. Management for Alvotech and Teva welcomed the FDA's acceptance. Thomas Rainey, senior vice president for US biosimilars at Teva, said it built on the firm's "shared commitment to improving patient outcomes by offering cost saving and accessible options."... Global Sub. Full

Research Reflects Need to Protect Access to Medicines in Europe

(2/20, The Pharma Letter) ...Teva is calling for the developing at full scale of the European Solidarity Mechanism to allow reallocation of existing market stocks to better address national shortages, the safeguarding of the economic viability of critical generic medicines by ensuring the systematic use of multi-winner, multi-criteria procurement schemes designed in collaboration with the industry, moving away from the lowest cost purchasing bid, to recognize the most valuable purchasing offer for the European healthcare system and economy... Sub. Req’d

Corcept Accused in California of Stifling Teva's Generic Launch

(2/20, Dulan Lokuwithana, Seeking Alpha) ...A group of health insurers has filed a lawsuit against Corcept Therapeutics in California, accusing the rare disease drugmaker of blocking Teva Pharmaceutical from marketing a generic version targeted at its best-seller Korlym... Full

Korean Court Rules in Favor of Samsung Bioepis Over Regeneron's Eylea

(2/21, Dong-jin Hwang, The Korea Economic Daily) ...A South Korean court on Friday ruled in favor of Samsung Bioepis Co. in a patent dispute against Regeneron Pharmaceuticals Inc., a US pharmaceutical firm...Industry watchers said the court ruling will likely clear a hurdle in Samsung's efforts to enhance its presence in the global biosimilar market, which is valued at over 12 trillion won, or $8.4 trillion... Full

Eli Lilly Bets Big On Weight-Loss Pill with $550 Million Inventory Stockpile

(2/20, Sriparna Roy, Reuters) ...Eli Lilly is betting big on its experimental oral weight-loss drug even before reporting data from its late-stage trial by recording nearly $550 million in "pre-launch inventory" in its financial statements, a filing showed on Wednesday. The move is unusual as it comes more than a year before the drug, orforglipron, is expected to be launched. Most drugmakers include such inventories, or assets, in their financial statements to show how much drug product has been manufactured right before approval... Full

Pfizer Inks Deal with Mylan Pharma to Market Ativan and Pacitane in India

(2/21, Sheersh Kapoor, CNBC TV-18) ...Pfizer Ltd has announced a strategic marketing and supply agreement with Mylan Pharmaceuticals Private Limited, aimed at bolstering the distribution and sales of its two well-known brands, Ativan and Pacitane, within India. The deal, which spans five years, was approved by Pfizer's Board of Directors following a meeting that concluded on February 21, 2025... Full

Novartis Fights MSN's Push to Delist Revived Entresto Patent

(2/20, Christopher Yasiejko, Bloomberg Law) ...Novartis AG is fighting MSN Laboratories Pvt. Ltd.'s efforts to pull a revived patent from Entresto's entry in the FDA's Orange Book, urging a Delaware federal judge to toss the generic-drug maker's "improper" counterclaim...Novartis argued in a separate brief Wednesday that the court should first rule on its motion to dismiss MSN's delisting counterclaim before considering an MSN request for judgment on the issue, saying allowing such a motion would be "futile and premature."... Sub. Req’d

ARS Pharmaceuticals Announces OptumRx, Cigna Healthcare and Navitus Health Systems Add Neffy® (Epinephrine Nasal Spray) to National Formularies, Further Expanding Coverage for Patients

(2/20, ARS Pharmaceuticals, Inc.) ...ARS Pharmaceuticals, Inc., a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from allergic reactions that could lead to anaphylaxis, announced today that Cigna Healthcare, Navitus Health Systems and OptumRx, through their Group Purchasing Organization (GPO) Emisar, have added neffy® (epinephrine nasal spray) to their National Formularies... Full

Drug Overdose Deaths Fall in 2023 for 1st Time Since Pandemic Began: CDC

(2/20, Mary Kekatos, ABC News) ...The rate of overdose deaths fell from 32.6 deaths per 100,000 people in 2022 to 31.3 per 100,000 people in 2023, a 4% decrease, according to the report from the Centers for Disease Control and Prevention's National Center for Health Statistics. Dr. Aitzaz Munir, an assistant professor of psychiatry at Rutgers New Jersey Medical School and associate program director for the Rutgers Addiction Medicine Fellowship Program, told ABC News the drop in the overdose death rate was "surprising" to him but a positive sign... Full

If You Can't Beat 'Em, Join 'Em

(2/21, Caitlin Owens, Axios) ...Pharmaceutical leaders kicked off Kennedy's tenure at the helm of HHS not with defensiveness or aggressiveness, but with declarations of optimism and mutual goal-sharing. "We have a disruptor-in-chief in President Trump and a new HHS secretary — both of which are committed to overturning the status quo," PhRMA president and CEO Steve Ubl said in his remarks at the industry group's policy forum this week...But at nearly the same time, Kennedy's welcoming remarks to HHS staff threw some cold water on the idea of an intimate partnership. After a long list of chronic disease statistics, he said, "Our only solution to these issues seems to be more and more pharmaceutical interventions that don't seem to be alleviating the problem, and in many cases, appear to be worsening it. Overmedication, particularly in children, is a growing issue."... Full

Trump CMS Offers Defense Of IRA In First Appellate Brief

(2/20, Gabrielle Wanneh, Inside Health Policy) ...The Trump administration on Wednesday (Feb. 19) filed its first brief in the Third Circuit Court of Appeals, defending Medicare's drug price negotiation program against a myriad of allegations of unconstitutionality from the drug industry -- establishing that although the drug industry hopes to work with President Donald Trump on revising and limiting the scope of the price-setting mechanism, the administration may not be on the same page... Sub. Req’d

Trump's HHS Defends Drug Price Negotiations in Novartis Suit

(2/20, Nicole DeFeudis, Endpoints News) ...Advocacy group Patients for Affordable Drugs said HHS' brief is a good sign for patients, "as the first round of negotiations delivered significant price reductions on some of the nation's most expensive drugs." But the group also cautioned that the future of the Medicare negotiations remains uncertain and "political pressure from Big Pharma remains strong." Novartis, which took part in the first round of negotiations for Entresto, told Endpoints News on Thursday that it "firmly believes the drug price-setting provisions in the IRA are unconstitutional."... Full

Drugmakers Tell Court to Keep Hospitals Out of Their 340B Rebate Suits

(2/20, Nicole DeFeudis, Endpoints News) ...Eli Lilly, Bristol Myers Squibb, Sanofi and Novartis are seeking to block a major hospital trade group from intervening in court cases over their proposed 340B drug rebate models..."Proposed Intervenors give no reason for this Court to believe that Manufacturer-Plaintiffs' models will result in covered entities receiving fewer payments than they are entitled to under the 340B statute," the drugmakers wrote. They added that the hospitals' alleged injuries rely on "several speculative links."... Full

Congresswoman Tenney Reintroduces PILLS Act to Promote Production of Generic Medicine in the U.S.

(2/20, Congresswoman Claudia Tenney) ...The generic drug industry is experiencing a movement toward centralizing production in India and China due to their significantly lower costs and looser manufacturing standards. This shift raises serious concerns about potential supply chain disturbances and inadequate drug safety measures. The PILLS Act offers pharmaceutical companies various tax incentives to enable them to shift all aspects of the manufacturing process for generic medicines, including materials and testing, to the United States... Full

Klobuchar, Grassley Introduce Bipartisan Legislation to Import Lower-Cost Prescription Drugs from Canada

(2/20, United States Senator Amy Klobuchar) ...U.S. Senators Amy Klobuchar (D-MN) and Chuck Grassley (R-IA) introduced the Safe and Affordable Drugs from Canada Act, which would allow Americans to safely import prescription drugs from Canada, lowering costs, increasing access for consumers, and creating more competition in the pharmaceutical market... Full

The Kennedy Era At HHS Begins … With Two Vaccine Approvals

(2/20, Michael McCaughan, Pink Sheet) ...Whether a coincidence or not, the FDA approved two vaccines the day after HHS Secretary Robert F. Kennedy Jr., who has many anti-vaccine views, took office. Even if Kennedy objected to the approvals, Kennedy would have had to make very quick work to block the approvals. Two non-vaccine approval announcements the same day also could align with Kennedy's agenda... Global Sub. Full

Dozens of Attorneys General Urge FDA to Crack Down On Counterfeit Obesity Drugs

(2/20, Ed Silverman, STAT) ...In a Feb. 18 letter to the agency, the state officials maintained that "supply shortages and high costs have created opportunities for wrongdoers to cash in and endanger consumers." In particular, they pointed to counterfeiters, online retailers selling active ingredients without requiring a prescription, and some compound pharmacies that "cut corners" in preparing custom-made versions of the drugs... Full

Senators Move Prior Authorization, PBM Regulations

(2/21, Whitney Downard, Indiana Capital Chronicle) ...Senators greenlit two health bills on Thursday ahead of a critical deadline with near-unanimous support — one limiting insurer's powers over prior authorization and another restricting pharmacy benefit managers... Full

Indian Drugmakers Can Retain US Dominance Even with Tariffs, Says Industry Body

(2/21, Rishika Sadam, Reuters) ...The Pharmaceuticals Export Promotion Council of India (Pharmexcil), set up by the trade ministry, said it believed that the Trump warning was mostly directed at costly imports of patented and other such products from other countries. "India pharma will not selectively be imposed high duties and its exports are highly competitive, so it can still compete in the newer environment (with import duties if at all imposed) without losing its share," Pharmexcil Director General Raja Bhanu told Reuters... Full

Drug Packaging Manufacturers Brace for Impact as EU Chemical Ban Looms

(2/20, Anna Brown, Endpoints News) ...Investors are concerned that the new law could force pharmaceutical packaging companies to alter their manufacturing processes to discontinue the use of these chemicals — potentially at great expense. Jefferies analysts noted that during the latest round of earnings calls with pharma manufacturers, there was an uptick in investor queries on what exactly a ban might mean for the sector... Full

Hip Pocket Relief, Faster Patient Access and More Patients Treated. The GBMA Releases its 2025-2026 Pre Budget Submission

(2/20, GBMA) ...In its 2025-2026 pre-budget submission, the Generic and Biosimilar Medicines Association (GBMA), prioritised the needs of those patients with complex conditions, such as Rheumatoid Arthritis, Crohn's Disease, Multiple Sclerosis and cancer1. With 61% of Australians struggling with the burden of one or more chronic conditions, timely access to more affordable treatment is critical... Full

France Finally Passes Price Cutting Finance Bill – With Some Amendments

(2/20, Francesca Bruce, Pink Sheet) ...The French senate has approved the controversial social security financing bill, providing pharma companies with more certainty. The new text includes some changes, such as a larger threshold for triggering clawbacks. Industry experts expect tough discussions regarding cost-saving mechanisms when it comes to the next social security financing bill for 2026... Global Sub. Full

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