Wednesday, March 19, 2025

Lilly, J&J, Pfizer and Sanofi Back Teva Fight Against IRA Drug Negotiation Program

(3/18, Kevin Dunleavy, Fierce Pharma) ...As a drugmaker depending heavily on sales of both branded and non-branded products, Teva has said that it is uniquely affected by how medicines are selected for the Medicare drug price negotiation program in the Inflation Reduction Act (IRA)...Also supporting Teva's effort is Bausch and the Biotechnology Innovation Organization (BIO) trade organization. Also weighing in with a proposed amicus brief is the Association for Accessible Medicines (AAM), which represents manufacturers and distributors of biosimilar and generic medicines... Full

IRA Round 2 Begins as Drugmakers Sign On to Price Negotiation Process with CMS

(3/18, Zoey Becker, Fierce Pharma) ...Now that the required agreements have been signed, the Centers for Medicare & Medicaid Services will spend the next few months collecting input from patients, clinicians and other "interested parties" before floating its initial maximum fair price offer no later than June 1, the agency announced in a statement. After that, companies will have 30 days to accept or submit a counteroffer. CMS will offer the companies a total of three negotiation meetings before the negotiation period ends on November 1... Full

Alvotech and Dr. Reddy's Announce FDA Acceptance of Biologic License Application for AVT03, A Proposed Biosimilar to Prolia® and Xgeva®

(3/18, Alvotech and Dr. Reddy’s) ...Dr. Reddy's Laboratories Ltd. and Alvotech...today announced that the U.S. Food and Drug Administration has accepted a 351(k) Biologic License Application submission for AVT03, developed by Alvotech, a proposed biosimilar of Prolia® (denosumab) and Xgeva® (denosumab)... Full

Daewoong Launches Stoboclo, First Prolia Biosimilar for Osteoporosis in Korea

(3/19, Yeom Hyun-a, Chosun Biz) ...Daewoong Pharmaceutical officially launched Celltrion Pharm's osteoporosis treatment Prolia biosimilar, "Stoboclo," in the domestic market on the 19th. Stoboclo is the first domestic biosimilar of Prolia...Stoboclo is priced 28% lower than the original drug, increasing treatment accessibility for patients... Full

Samsung Biologics, Hanmi Pharmaceutical Partner to Sell Prolia Biosimilar in Korea

(3/19, Heo Ji-yoon, Chosun Biz) ...The two companies announced on the 19th that they held a joint sales agreement signing ceremony for the domestic launch of the osteoporosis treatment Prolia biosimilar (active ingredient denosumab) on the 18th at Hanmi Pharmaceutical's headquarters, Park Hall. Samsung Bioepis is currently undergoing the approval process for the Prolia biosimilar in the domestic market, while it obtained approval in the United States and Europe in February... Full

Pfizer Sells Entire Haleon Stake for $3.24 Billion

(3/19, Anandita Mehrotra, Reuters) ...Drugmaker Pfizer has sold its entire stake in Haleon for about 2.5 billion pounds ($3.24 billion) to institutional investors and the consumer healthcare firm at 385 pence per share, a bookrunner for the deal said on Wednesday... Full

Purdue Pharma Files New Bankruptcy Plan for $7.4 Billion Opioid Settlement

(3/19, Dietrich Knauth, Reuters) ...The formal bankruptcy plan filed Tuesday, in White Plains, New York, fleshes out the settlement with new details about how the money will be allocated to states, local governments and individuals harmed by the crisis. The cash value of the plan assumes full creditor participation. Purdue said it expects widespread creditor support for the deal... Full

Optum to Drop Prior Authorization Requirement for Dozens of Drugs

(3/19, Caitlin Owens, Axios) ...The company identified drugs that are "no longer clinically necessary to review" every year, said Patrick Conway, CEO of Optum Rx. These include medications for cystic fibrosis, asthma and other chronic diseases. "We can make it simpler for doctors, pharmacists and patients," Conway said. The change will eliminate up to one-quarter of total drug reauthorizations, the company said. The program begins on May 1, and the list of included drugs will expand over time... Full

What Companies Can Do To Address Prescription Drug Market Manipulation

(3/18, Jake Frenz, Forbes) ...In The Great American Drug Deal: A New Prescription for Innovative and Affordable Medicines, Peter Kolchinsky, biotechnology thought leader, advocates for a system where drugs enjoy a period of patent protection to incentivize research and development. Once this period ends, Kolchinsky believes generics should be introduced to lower prices and make the medication more accessible... Sub. Req’d

Medicare Part D Spending Cap Will Save Seniors $7Bn in 2025, HHS Data Suggests

(3/18, Carina Belles, Pink Sheet) ...An ASPE report released before President Trump took office found that beneficiaries could save $7bn on prescription drugs thanks to the new Medicare Part D spending cap. Each enrollee is expected to save about $600 annually, but those who do not receive the low-income subsidy would save more. Patients with CF, multiple myeloma or other major health conditions and not LIS eligible also could see substantial savings on drug costs in 2025... Global Sub. Full

NAHPC CEO: Souped-Up Value Assessment Entity A Much-Needed Rx Pricing Reform

(3/18, Gabrielle Wanneh, Inside Health Policy) ...The establishment of government-endorsed value assessment entities to ferret out the fairest value of prescription drugs when they enter market would provide employers and health care purchasers a different way of determining where to place new treatments in their formularies without having to engage with the current rebate model that comes with perverse incentives for pharmacy benefit managers and insurers to favor preferential placement for the most expensive drugs, Shawn Gremminger, president and CEO of the National Alliance of Healthcare Purchaser Coalitions (NAHCP), recently told Inside Health Policy... Sub. Req’d

How Price Setting Undermines IP And Restricts Access to Medicines

(3/18, Brad Watts, U.S. Chamber of Commerce) ...The Bottom Line: To ensure continued patient access to life-saving treatments, Congress must reinforce strong IP rights and reconsider policies that undermine them... Full

RFK Jr.'s HHS Picks Up Biden Admin Legal Fight Against 340B Rebates

(3/18, Dave Muoio, Fierce Healthcare) ...The Department of Health and Human Services (HHS) has filed for summary judgment in its favor regarding lawsuits brought by pharmaceutical companies that attempted to reinvent hospital discounts through the 340B Program—the first explicit sign that the new administration is taking up its predecessor's stance on the controversial industry issue... Full

The Issue with Reissue: PTE Edition

(3/19, Sara W. Koblitz, FDA Law Blog) ...Integral to the careful balance Congress struck when passing the Hatch-Waxman Amendments, the patent term extension (PTE) is intended to restore patent life that was consumed during regulatory review of an FDA-regulated product. Even though the PTE provisions established in the Drug Price Competition and Patent Restoration Act are forty-plus years old, courts are still grappling with questions about how to best implement the Patent Term Extension. And just last week, a new question was answered by the Federal Circuit: how is a patent term extension calculated for a reissued patent... Full

Unfreezing US FDA: Generic Drug Officials Make Plea For Public Workshops

(3/18, Michael McCaughan, Pink Sheet) ...Expanding the opportunities to use controlled correspondence was a key element of the most recent generic drug user fee program reauthorization..."You might have noticed that this is the first event that we have had since the new administration," Robert Lionberger, director of the OGD Office of Regulatory Science, said at the close of the meeting. "Everyone involved in this really had to go through some extra efforts to make this event happen today. We really hope that you found it valuable for your work in developing generic products."... Global Sub. Full

Federal Workforce Shrink Could Cripple FDA Drug & Device Inspections

(3/18, Maaisha Osman, Inside Health Policy) ...A slowdown in inspections could have significant consequences for pharmaceutical companies awaiting FDA approvals. Facilities that previously failed inspections and are under Official Action Indicated (OAI) status need to be re-evaluated before resuming exports to the United States. Similarly, pre-approval inspections are necessary for new drug applications. Without timely evaluations, pending approvals could face substantial delays, affecting the availability of essential medications... Sub. Req’d

20 US States Balk at Florida Settlement With Drugmaker Sandoz

(3/18, Mike Scarcella, Reuters) ...The states, along with the District of Columbia and U.S. Virgin Islands, in a court filing on Monday challenged a part of Florida's settlement that they said could bar other states from settling for more than Florida did, for up to four years... Full

IGBA's Susana Almeida On Consensus Building, Harmonization, And Policy Built On Science – Not Politics

(3/18, Urte Fultinaviciute, Generics Bulletin) ...In a fast-paced world, change is expected to happen overnight. But when you mix global harmonization and policy, it is not as easy. This also applies to the off-patent industry. "Progress is very slow, it's true, but we are walking there. We wish we could walk faster," the International Generic and Biosimilar Medicines Association's secretary general Susana Almeida told Generics Bulletin. Talking on the sidelines of the recent 3rd Bioequivalence conference at the end of February, Almeida agreed that global convergence and harmonization can be slow. But putting things into perspective, over the past two decades, the industry has celebrated quite a few achievements... Global Sub. Full

Joint Strategy Sets Direction of EMA and EU Medicines Regulatory Agencies to 2028

(3/18, European Medicines Agency) ...The strategy, titled ‘Seizing opportunities in a changing medicines landscape', is a comprehensive update of the five-year strategy which was developed to cover the period 2021 to 2025 (EMANS 2025). The updated document will guide the European medicines regulatory network over the next few years to meet the challenges ahead, including preparing for, and responding to, public health emergencies and threats such as antimicrobial resistance... Full

As Pharmacies Run Low On Supplies, Drug Shortages Must Be Treated as Crisis of National Security

(3/18, Adam Luck, Daily Mail) ...Turbulence in the global supply chain of medicine - triggered by the Covid pandemic and the war in Ukraine - have meant the UK has been competing with other countries for dwindling medicine supplies. Now one of the UK's leading pharmaceutical industry experts has warned repeated drug shortages are a matter of 'national security' and called on the Government to ensure the UK can supply its own needs... Full

Daniel Bran is the New President of the Romanian Association of Generic Medicine Producers

(3/18, Simona Hrincescu, Business Review) ...The Romanian Association of Generic Medicine Producers (APMGR) announces the appointment of Daniel Bran as the new President of the association. He takes on this role at a crucial time for the pharmaceutical industry, with the goal of enhancing patient access to essential medicines and supporting a predictable and sustainable legislative framework for the producers of generic and biosimilar medicines in Romania... Full

MEP: Incentives for Innovation Needed to Face Trump's Pharma Pressure

(3/19, Sarantis Michalopoulos, Euractiv) ...Europe's legal framework should provide the pharma industry with incentives to innovate and ultimately, move to or stay in the bloc, socialist EU lawmaker Nicolás González Casares told Euractiv in an interview... Sub. Req’d

Editorial: The Irish Times View On Ireland and Big Pharma: State Faces Risks from Overreliance

(3/19, The Irish Times) ...Now that Ireland's exports are under threat from Donald Trump's tariff plans, there are suddenly fears about the impact on tax revenue and jobs. The pharma sector is at the centre of this story, because of its significant exports from plants here back to the US market. Trump has been clear that he wants these products to be manufactured in the US, rather than offshore locations like Ireland. How this plays out promises to be a high stakes story for Ireland and its economy... Full

Sandoz Canada and Delpharm Sign 10-Year Supply Agreement

(3/18, Canadian Manufacturing) ...Sandoz Canada has signed a 10-year, long-term supply agreement with Delpharm. This partnership, along with financial backing from the Government of Canada, will allow Delpharm to carry out its modernization plan for its Boucherville plant... Full

India Should Negotiate US Tariffs from a Position of Strength: Former Pharmexcil DG

(3/18, PT Jyothi Datta, The Hindu BusinessLine) ...India should negotiate from a position of strength and not reduce import duties under the threat of "retaliatory" tariffs from the United States, as "it would set a precedent", says former Director-General of the Pharmaceuticals Export Promotion Council (Pharmexcil) R Uday Bhaskar... Full

Pharmexcil Pushes for Market Access as US Mulls Tariffs On Indian Drugs

(3/18, Neetu Chandra Sharma, Business Today) ...Amid looming U.S. tariff hikes on imported active pharmaceutical ingredients (APIs) and finished pharmaceutical formulations, government-backed trade promotion body the Pharmaceuticals Export Promotion Council of India (Pharmexcil) is stepping up efforts to secure greater market access and policy support, with the ambitious goal of pushing India's pharmaceutical exports to $65 billion by 2030... Full

Big Pharma's Plea to Trump to Punish Australia for Cheaper Medicines

(3/19, David Crowe, The Sydney Morning Herald) ...American medical giants have slammed the $18 billion pharmaceutical benefits scheme in a plea to US President Donald Trump to impose punitive tariffs on Australia because it subsidises medicines for millions of patients...The PhRMA submission dedicates a section to Australia alone and blames the Pharmaceutical Benefits Advisory Committee, the expert group that advises the government, for putting barriers in the way of American exports... Full

Australia Defends Pharmaceutical Benefits Scheme as US Companies Urge Trump to Impose Reciprocal Tariffs

(3/19, Stephanie Dalzell, Stephen Dziedzic and Tom Crowley, ABC News) ...Health Minister Mark Butler and Coalition health spokeswoman Anne Ruston have vowed to keep the PBS off the table in any trade discussions with the Trump administration before the president's decisions next month on another round of US tariffs on other countries. But the formal US industry position heightens the prospect of reciprocal tariffs on Australian medical companies as a way to force change to the federal government policy and extract better terms for American drugmakers... Full

China Signals Commercial Insurance, Biotech And Foreign-Owned Hospitals As Policy Priorities

(3/19, Xu Hu, Pink Sheet) ...In the biopharma and healthcare sector, the central government again showed its desire to open up the biotechnology sector, allow wholly foreign-owned hospitals and reform the drug reimbursement system by including these areas in the main tasks to tackle this year. This also echoes national policies and discussions related to insurance coverage for innovative drugs discussed at pharma industry conferences in 2024... Global Sub. Full

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