Friday, December 19, 2025

Alvotech, Teva Reach Settlement and License Agreement with Regeneron for AVT06

(12/19, The Fly) ...Alvotech and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical announced that they have reached a settlement and license agreement with Regeneron concerning the launch of AVT06, Alvotech's proposed biosimilar to Eylea in the United States. The settlement grants a license entry date for AVT06 in the United States in the fourth quarter of 2026, or earlier under certain circumstances... Sub. Req’d

Alvotech And Teva Are Latest With US Eylea Settlement

(12/19, Dave Wallace, Generics Bulletin) ..."Following recent marketing approvals in both Europe and Japan, we are delighted to secure a US settlement date for our biosimilar candidate to Eylea, an important biologic for the treatment of retinal diseases," commented Alvotech founder, chairman and CEO Robert Wessman. "This positions Alvotech and our commercial partner Teva very well for a successful launch in the US market next year, pending FDA approval."... Sub. Req’d

Novartis, Roche Back US Efforts to Lower Drug Costs Amid Talk of Pricing Deal

(12/18, Reuters) ...Novartis said it is in discussions with the Trump administration and is committed to finding solutions that lower costs for Americans and address price disparities between the United States and other high-income countries. "We believe all countries should appropriately value and contribute fairly to the cost of innovation so that patients everywhere can benefit without delay," Novartis said...A person familiar with discussions over trade said a drug pricing deal involving the two pharma companies could be getting closer but declined to say how imminent it was... Sub. Req’d

Several Top Drugmakers to Lower US Prices for Some Drugs-Sources

(12/19, Michael Erman, Jarrett Renshaw and Patrick Wingrove, Reuters) ...AbbVie, Bristol Myers Squibb, Gilead, Merck and other drugmakers are expected on Friday afternoon to announce agreements with the U.S. government to lower certain prescription drug prices, according to sources familiar with the situation... Full

Lutnick Says More Drug Pricing Announcements Before End of Year

(12/18, Yash Roy, Bloomberg) ...The US may announce more drug pricing deals before the end of the year, Commerce Secretary Howard Lutnick says on Fox News. "He's got more announcements even between now and the end of the year," Lutnick says about potential announcements from President Trump... Sub. Req’d

Howard Lutnick Addresses Trump's ‘Mathematically Impossible' Claim He's Cutting Drug Prices by 600% During Fox News Grilling

(12/18, Rhian Lubin, The Independent) ...Commerce Secretary Howard Lutnick has attempted to explain President Donald Trump's "mathematically impossible" claim that he is cutting drug prices by up to 600 percent after being grilled by a Fox News host..."What he's saying is…if a drug was $100 and you bring the drug down to $13 right? If you're looking at it from $13 it's down seven times…" Lutnick attempted to explain in a rambling response. "It's 700 percent higher [than] before, it's down 700 percent now, right? So $13 would have to go up 700 percent to get back to the old one," Lutnick continued. "So it all depends on when you look at it... Full

BIOSECURE 2.0 Signed Into Law After Final Tweaks

(12/19, Xu Hu, Pink Sheet) ...Following the US Senate's passage of the fiscal 2026 National Defense Authorization Act (S. 1071) on Dec. 17, US President Donald Trump signed the act into law on Dec. 18, including under its cover a revised version of the BIOSECURE Act, which could have important implications for the biopharma industry... Global Sub. Full

Biosimilars Forum Applauds FDA Commissioner Dr. Marty Makary for Supporting Safe, Effective and Lower-Cost Biosimilars

(12/18, Biosimilars Forum) ..."Now more than ever, it is clear that biosimilars—safe, effective, and lower-cost medicines that reference biologics—are key to fixing America's healthcare affordability crisis. Nearly 30% of Americans say they have not taken their medication as prescribed due to unaffordable prices. This reality means that today's updated guidance from FDA Commissioner Makary on biosimilars is a momentous, critical step in unlocking the potential of these modern treatments to lower prescription drug prices for all Americans."... Full

Major Drug Pricing Regulation Moves Forward

(12/18, Caitlin Owens, Axios) ...The regulation, which appears to tie what the U.S. pays for some drugs to the prices in other countries, would be the administration's most aggressive step yet to lower U.S. drug prices...The proposed regulation, titled the "Global Benchmark for Efficient Drug Pricing (GLOBE) Model," completed review on Wednesday, according to OMB's website... Full

Senator Marshall Introduces Bipartisan Legislation to Hold Pharmacy Benefit Managers Accountable

(12/18, U.S. Senator Roger Marshall) ...The PBM Fiduciary Accountability, Integrity, and Reform Act, or PBM FAIR Act, would require PBMs to operate as fiduciaries, obligating them to prioritize the financial and health interests of ERISA-covered group health plans in every decision they make. By doing so, the legislation would help prevent PBMs from doing things like steering plans toward higher-cost branded drugs with larger rebates when lower-cost generics or biosimilars are available... Full

Rx Inspector: ProPublica's New Tool Provides Drug Info the FDA Won't

(12/18, Megan Rose and Debbie Cenziper, ProPublica) ...Today, ProPublica is launching Rx Inspector, a first-of-its-kind database that provides answers to what the FDA won't tell us: where our generics are coming from and the track records of the factories that made them. The information is harder to find than you may think... Full

How We Created a Tool That Tells You Where Your Generic Drugs Were Made

(12/18, Brandon Roberts, Nick McMillan, Ruth Talbot, Kevin Uhrmacher and Ken Schwencke, ProPublica) ...You can look up your generic prescription drugs, and we'll guide you to the specific facility that made them. We were able to link more than 80% of generic prescription drug products in our database to a factory that made them using databases of label information, manufacturing facilities and location data that we sued the FDA for. Additionally, we included the history of FDA actions at those facilities based on a trove of inspection records we assembled... Full

US FDA Plans More Sentinel Growth, But Industry Questions Paying With User Fees

(12/18, Derrick Gingery, Pink Sheet) ...Industry already has proposed removing user fee funding for Sentinel, along with several adjustments that can increase the annual revenue target and individual fees...Sentinel 3.0 would be staffed by the FDA and supported by a contractor that would collaborate with agency staff as needed. Data will reside in the data platform environment, which will have appropriate security controls and accessibility rules, the agency wrote in the RFI... Global Sub. Full

F.D.A. Turmoil Keeps Spotlight on Its Commissioner

(12/19, Christina Jewett, The New York Times) ...The tumult at the F.D.A., though, reflects a jarring year defined by the loss of thousands of agency staff members, a rapidly spinning door of top leaders and conflicting statements and actions related to drug approvals. The biotech industry has also pressured the White House about the agency's refusal to approve a number of drugs... Full

FDA Voucher Program Has Become Vehicle for Political Interference in Drug Review Decisions, Staffers Say

(12/19, Lizzy Lawrence, STAT+) ...The FDA has historically aimed to keep drug reviews in the hands of career scientists to avoid political interference, or even the appearance of political interference. But STAT has learned that high-level FDA officials have been involved in every part of the new program to award "Commissioner's National Priority Review" vouchers. They have awarded at least one voucher over the concerns of staff, and pressed staff to award vouchers to certain companies as part of the drug-pricing agreements being struck by the White House... Sub. Req’d

FDA Finalizes Safety Reporting Guidances for Sponsors and Investigators

(12/18, Joanne S. Eglovitch, Regulatory Focus) ...The guidance is intended to help investigators identify serious adverse events (SAEs) that must be immediately reported to the sponsor. It also identifies the safety information that is considered an unanticipated problem involving risk to human participants requiring prompt reporting to institutional review boards (IRBs)... Full

FDA Loosens Restrictions on Using Patient-Level RWD in Medical Device Submissions

(12/18, Joanne S. Eglovitch, Regulatory Focus) ...The move acknowledges the position of sponsors and data scientists that meaningful information can be derived from certain big data sources that do not catalog individual-level personal information. FDA reviewers will now assess the strength of submitted RWE on an application-by-application basis... Full

Takeda's AI-Crafted Psoriasis Pill Succeeds in Late-Stage Studies

(12/19, Reuters) ...More than half of the plaque psoriasis patients across the studies showed clear or almost clear skin after 16 weeks of treatment with the once-daily drug, zasocitinib, the company said. Takeda plans to file marketing applications with the U.S. Food and Drug Administration and other regulatory authorities in 2026... Full

Lilly's Obesity Pill Is the First Oral GLP-1 to Show Its Worth in the Maintenance Setting

(12/18, Elizabeth Cairns, Endpoints News) ...Eli Lilly's experimental obesity pill allowed patients who had lost weight on injected GLP-1-based drugs to keep most of the weight off for another year, according to data from a Phase 3 trial released Thursday. This maintenance setting is a new frontier for weight loss meds, and could be an important one for oral therapies. US approvals of Lilly's oral candidate, called orforglipron, and Novo Nordisk's rival obesity pill are expected soon... Sub. Req’d

Fresenius Kabi Introduces First-Ever Rocuronium Bromide Injection Stable at Room Temperature

(12/18, Fresenius Kabi) ...Because it can be stored at room temperature, Rocuronium Bromide Injection RTS is expected to reduce the cost and complexity of transportation and storage because a cold supply chain is not needed. Hospital pharmacies can store Rocuronium Bromide Injection RTS at room temperature, which can free up refrigerated space for other medications... Full

Federal Lawsuit Accuses Teva of Colluding With Pfizer to Delay Releasing Generic Drugs

(12/18, James Dornbrook, Kansas City Business Journal) ...The lawsuit accuses Teva of orchestrating a scheme to delay its release of a generic version of the EpiPen, a Pfizer-owned drug used for emergency treatment of life-threatening allergic reactions. In return, Pfizer allegedly agreed to delay the release of a generic version of Nuvigil, a Teva-owned drug used to treat narcolepsy and other sleep disorders... Sub. Req’d

Zydus Unit Ties Up With Formycon AG to Supply Biosimilar in US, Canada

(12/19, PTI) ...Under the terms of this agreement, Formycon AG will develop, register, manufacture and supply the product, while Zydus Lifesciences Global FZE will be responsible for the commercialisation of FYB206 in the defined territories, the Ahmedabad-based drug maker said in a statement... Full

First Natalizumab Biosimilar Tyruko Launches, Expanding Access in Multiple Sclerosis

(12/18, Skylar Jeremias, The Center for Biosimilars) ...Keren Haruvi, president of Sandoz North America, said the biosimilar could help expand access to natalizumab for people experiencing disease relapse while introducing competition that may support health care savings. Leslie Ritter, vice president of health care access at the National MS Society, described biosimilar availability as an important step toward addressing affordability and access barriers... Full

2025 Is A Year Of Firsts As Biosimilars Build Momentum In US

(12/19, Dave Wallace, Generics Bulletin) ...Shortly after Amgen's launch, the following month Teva confirmed that it had introduced its Samsung Bioepis-partnered Epysqli (eculizumab-aagh) biosimilar – with the Israeli firm's development partner also revealing details of the pricing strategy for the rare diseases treatment. However, with only two biosimilars in the market, the degree of discounting was nowhere near the level seen for Stelara and Humira before it... Sub. Req’d

Want to Bring Your Drug Prices Down? Publix, Others Offer Ways

(12/18, C.A. Bridges, USA Today) ...Discount Finder is available online or in the Publix app. Enter the name of a medication, and the service will display a range of prices with coupons from different sources that can be texted, emailed, or printed... Full

US And Canada Unite To Cut Duplication In Generic Drug Reviews

(12/18, Anabel Costa-Ferreira, Pink Sheet) ...The US Food and Administration and Health Canada launched the Request for Information Sharing (RIS) program on Dec. 1, building on a nearly two-year pilot. The initiative aims to support regulatory alignment and enhance patient access to high-quality, safe and effective generic medicines in both countries... Global Sub. Full

UK Committee Demands ‘Much-Needed Clarity' on UK-US Pharma Trade Deal

(12/18, Anna Brown, Endpoints News) ...Chi Onwurah, the chair of the Science, Innovation and Technology Committee...requested more information on how much the deal will cost the UK each year, and whether the funding will be taken from budgets normally allocated to the UK's National Health Service. Onwurah addressed the letter to the UK's health secretary Wes Streeting and Liz Kendall, secretary of state for the UK's Department for Science, Innovation and Technology... Sub. Req’d

China's Biotech Sector Is Advancing Faster than Thought, US Commission Says

(12/19, Jared Whitlock, Endpoints News) ...In a report released early Friday morning, the National Security Commission on Emerging Biotechnology said that it had previously identified a three-year period for decisive action, but new evidence indicates that this window is closing faster than anticipated, with global power dynamics at stake... Sub. Req’d

EU Parliamentary Vote Takes Critical Medicines Act In ‘Troubling' Direction

(12/18, Francesca Bruce, Pink Sheet) ...A move to expand the regulation's definition of "medicinal products of common interest" to include products with an orphan designation could create "new unnecessary obligations and uncertainty for [orphan drug] companies, therefore undermining patient access to innovative rare disease therapies," said the group, which represents small to medium-sized companies in Europe... Global Sub. Full

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