Thursday, May 22, 2025

Teva, Novartis Get Fresh Warnings From FTC Over Orange Book Patent Listings

(5/21, Alexis Kramer, Endpoints News) ...The antitrust regulator on Wednesday sent a fresh round of warning letters to three Teva entities, Novartis, Amphastar Pharmaceuticals, Viatris' Mylan Specialty, and Covis Pharma. The letters allege that the companies failed to remove "improperly listed device patents" that cover treatments for asthma, diabetes and more from the patent database... Sub. Req’d

FTC Launches Third Crackdown On Orange Book Listings, Marking First Action Under Trump Admin

(5/21, Maaisha Osman, Inside Health Policy) ...In a letter sent to Teva's legal counsel this week, FTC warned that patents covering ProAir HFA, ProAir DigiHaler, ProAir RespiClick and QVAR inhalers remain improperly listed in FDA's database of approved drug products. The agency cited the 2024 ruling from the U.S. Court of Appeals for the Federal Circuit, Teva v. Amneal, which invalidated key listings and reinforced FTC's longstanding argument that such patents block lower-cost generics from entering the market... Sub. Req’d

Lupin CEO On Trump's Most Favored Nation Policy, Tariffs, Firm's Five-Year Plan

(5/21, Anju Ghangurde, Generics Bulletin) ...Lupin CEO Vinita Gupta discussed the Indian company's response to Trump's most favored nation policy and the Inflation Reduction Act during an investor meet. Management outlined a five-year plan emphasizing growth from complex generics and technology platforms, projecting significant revenue from products like tolvaptan and mirabegron. The firm reported a 14.2% year-on-year rise in Q4 FY25 revenue from operations at INR56.7bn ($662m), while net profit for the quarter jumped 112.5% YoY to INR7.8bn... Global Sub. Full

Formycon Hopes Stelara Biosimilar Sales To Pull Through FY2025 As Q1 Revenues Slump

(5/22, Urte Fultinaviciute, Generics Bulletin) ...Formycon affirmed its full-year sales guidance of €55m to €65m, aiming for improved revenues in the latter half of 2025, driven by its ustekinumab biosimilar Otulfi. The firm is also pursuing partnering opportunities for its Keytruda rival and other early-stage biosimilars. Uncertainty remains regarding the launch timeline for the firm's aflibercept biosimilar due to ongoing litigation with originator Regeneron... Global Sub. Full

Sandoz Rolls Out Europe's First Stelara Biosimilar Autoinjector

(5/22, The Pharma Letter) ...Swiss biosimilars specialist Sandoz has launched what it says is the first autoinjector presentation of a biosimilar to Stelara (ustekinumab) in Europe, bolstering its presence in the region's rapidly expanding immunology market. The product, branded as Pyzchiva (ustekinumab), was developed by Samsung Bioepis and is being commercialized by Sandoz under a 2023 agreement that grants it exclusive marketing rights in Europe, the UK, USA and Brazil... Sub. Req’d

Celltrion Secures 2nd Major US PBM Contract for Steqeyma

(5/22, Lee Han-soo, Korea Biomedical Review) ...With this latest deal, Steqeyma will be eligible for reimbursement under the PBM's private insurance plans starting July 1. The agreement marks the second major formulary listing secured by Celltrion within weeks of the product's U.S. launch in March. On April 3, the company announced a similar deal with one of the top three PBMs in the U.S., covering both public and private insurance formularies... Full

ANI Raises Generics Guidance As Exclusive Prucalopride Drives Growth

(5/21, Dean Rudge, Generics Bulletin) ...ANI Pharmaceuticals has reported record Generics revenues of $98.7m in the first quarter, an increase of 40.5% year-over-year. The firm's US generic version of Takeda's Motegrity (prucalopride) tablets with 180 days of competitive generic therapy (CGT) exclusivity was a key growth driver, although revenues from the product are expected to decline in Q2. On the back of its growth, ANI now expect mid-double-digit growth from its Generics business for the full year, up from its prior estimate of low-double-digit growth... Global Sub. Full

Gedeon Richter Feels Biosimilar Model ‘Is Looking For An Equilibrium'

(5/22, Dean Rudge, Generics Bulletin) ...Hungarian firm Gedeon Richter plans to launch four biosimilars within the next year, aiming to navigate a crowded market for denosumab. The firm's CEO Gábor Orbán discussed the company's strategy during their first-quarter earnings call, noting that the biosimilar model is still seeking equilibrium. Richter reported a 14% increase in Biotechnology revenues in Q1, driven mostly by increasing contract development and manufacturing operations... Global Sub. Full

Samsung Biologics to Spin Off Biosimilar Unit Samsung Bioepis

(5/21, Dae-Kyu Ahn, The Korea Economic Daily) ...Samsung Biologics, the biotechnology unit of South Korea's top conglomerate Samsung Group, said in a regulatory filing on Thursday that it will establish a new holding company – tentatively named Samsung Epis Holdings – to oversee Samsung Bioepis and other biosimilar and new drug development businesses. Analysts said the move is intended to clarify the business structure, unlock corporate value and reinforce Samsung Group's presence in the high-margin pharmaceuticals sector... Full

Durham-Based Satsuma Wins FDA Approval for Migraine Treatment

(5/21, Kyle Marshall, Satsuma Pharmaceuticals) ...Following a regulatory setback last year, Satsuma Pharmaceuticals Inc. has won approval for its nasal powder migraine treatment device from the U.S. Food and Drug Administration. Satsuma, a unit of a Japanese drugmaker with U.S. headquarters in Durham, said its treatment, called Atzumi, received its new drug application approval from the FDA. The approval covers Atzumi for the treatment of acute migraine in adults, both with and without aura, or sensory disturbances that sometimes accompany migraine... Full

Cigna Announces New Deal for Copay Caps On Eli Lilly and Novo Nordisk Weight Loss Drugs

(5/21, Bertha Coombs, CNBC) ..."This solution is really focused towards clients that aren't covering it today, and what it allows us to do is one, to bring it on at a reduced price for the plan sponsor, but also capping out the members' cost at $200," per month said Harold Carter, Evernorth senior vice president of pharmacy relations... Full

Prices for New US Drugs Doubled in 4 Years as Focus on Rare Disease Grows

(5/22, Deena Beasley, Reuters) ...U.S. prices for newly-launched pharmaceuticals more than doubled last year compared to 2021, as companies leveraged scientific advances to develop more therapies for rare diseases, which typically command high prices, a Reuters analysis found. The median annual list price for a new drug was over $370,000 in 2024, according to the Reuters survey of 45 medicines. In 2021, the median price was $180,000 for the 30 drugs first marketed through mid-July, according to a study published in JAMA based on the same criteria. The median launch price was $300,000 in 2023 and $222,000 in 2022... Full

Sanders Reintroduces MFN Bill But Cassidy Blocks Fast-Track Vote

(5/21, Maaisha Osman, Inside Health Policy) ...In a dramatic showdown on the Senate floor Wednesday, Senate health committee ranking member Bernie Sanders (I-VT) reintroduced his bill on "most favored nation" policy to slash U.S. prescription drug prices by linking them to prices in other wealthy nations ---- but his bid to fast-track the measure through unanimous consent was swiftly blocked by committee Chair Bill Cassidy (R-LA) who said he was working on alternative legislation... Sub. Req’d

Klobuchar, Welch, Colleagues Introduce Legislation to Expand Medicare Drug Price Negotiation and Lower Costs for Americans

(5/21, United States Senator Amy Klobuchar) ...U.S. Senators Amy Klobuchar (D-MN) and Peter Welch (D-VT) reintroduced the Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act. This legislation would expand Medicare negotiation of drug prices to lower drug costs for consumers, reduce federal spending, and give the Department of Health and Human Services stronger tools to negotiate lower drug prices in Medicare Part B and Part D... Full

How the IRA's Part B Coinsurance Inflation Adjustments Can Raise Seniors' Drug Costs

(5/21, Adam J. Fein, Ph.D., Drug Channels) ...Though CMS touts that the IRA's inflation-based coinsurance adjustments will "lower out-of-pocket costs," the results have been more complicated. Below, we update and expand on our previous analysis. We find that a growing number of Part B drugs now have inflation-adjusted coinsurance rates that are rising, not falling. In many cases, the rate dips temporarily before snapping back to the standard 20%. Even more troubling, these fluctuations have led to unexpected increases in patients' out-of-pocket expenses—even when a drug's price was declining. These unpredictable coinsurance shifts are another example of the IRA's unintended consequences. Rather than enjoying stable or reduced costs, some seniors are finding themselves on a financial rollercoaster... Full

The Economics of Generic Drug Shortages

(5/21, Rena M. Conti and Marta E. Wosinska, Brookings) ...Marta Wosinska and Rena Conti, in a new paper published by the Journal of Economic Perspectives, examine the economic puzzle behind drug shortages in the generic drug market...In their research, Wosinska and Conti find that this challenge can be explained by the inability of generic drug prices to adjust to regulatory and contracting frictions, as well as the presence of asymmetric information and agency problems within the U.S. drug market. To address these frictions, they conclude with a discussion of various policy interventions targeted at ameliorating these economic challenges and ensuring a resilient U.S. generic drug supply... Full

Don't Let Patients Become Collateral Damage in a Trade War

(5/21, Andrew Spiegel, RealClearHealth) ...Tariffs on such essential components, as well as finished medicines imported from Europe, would drive up production costs and upend supply chains, simultaneously threatening workers' jobs and disrupting patients' access to medicines. The resulting disruptions would particularly undermine the impressive progress that scientists have made against cancer...Medicines have historically been exempt from tariffs, and patients should never be collateral damage in a trade war. President Trump can show he's committed to lowering healthcare costs by keeping life-saving medicines out of the crossfire... Full

New "Balance the Scales" Campaign Highlights Why Americans Pay More for Prescription Medicines

(5/21, Alex Schriver, PhRMA) ...The Pharmaceutical Research and Manufacturers of America today launched a new campaign to highlight why the United States pays higher drug prices than other countries and what policymakers can do to strike a better deal for American patients, taxpayers and employers. Entitled "Balance the Scales," the ad is being released as there is an increased focus on international price differences... Full

FDA Announces Efforts to Facilitate Drug Importation from Canada 

(5/21, Nicole DeFeudis, Endpoints News) ...The FDA said on Wednesday that it would offer states and tribes the opportunity to submit a "draft proposal for pre-review and meet with the agency to obtain initial feedback" prior to officially submitting their proposal for a Section 804 Importation Program, also known as a SIP... Sub. Req’d

US FDA Will Help States Apply To Import Cheaper Drugs From Canada

(5/21, Cathy Kelly, Pink Sheet) ...The FDA will help states and Indian tribes develop proposals for importing cheaper drugs from Canada in an effort to revive the largely dormant program. But the agency has not signaled a change in the importation rules, which set a high bar for ensuring the safety of imported drugs and demonstrating they will save consumers money. Without relaxing the rules, further implementation of the policy will be "difficult" to pursue, said former FDA Commissioner Scott Gottlieb... Global Sub. Full

HHS Says It Will Make Unspecified Changes To FDA's REMS Webpage

(5/21, Jessica Karins, Inside Health Policy) ...FDA is providing notice that it intends to make changes to its website on risk evaluation and mitigation strategies (REMS) for drugs, raising alarms for plaintiffs suing the government over the agency's deletion of health-related webpages and who say it's unclear what changes FDA intends to make and whether they're authorized under any executive order from President Donald Trump... Sub. Req’d

California Doctors Target Health Insurers Over Specialty Drugs

(5/22, Andrew Oxford, Bloomberg) ...Physician groups want to allow their patients to get such drugs from their doctors, or a hospital pharmacy. The groups are backing legislation (AB 577) that targets the practice by insurers and their related pharmacy benefit managers, which negotiate prices with drugmakers and manage prescription benefits for employers... Sub. Req’d

IGBA Welcomes ICH New Topic for Harmonisation: Framework for Determining Utility of Comparative Efficacy Studies in Biosimilar Development Programs

(5/21, IGBA) ...The International Generic and Biosimilar medicines Association commends the General Assembly of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) for its adoption of a new topic focused on the harmonisation of "Framework for Determining Utility of Comparative Efficacy Studies in Biosimilar Development Programs."... Full

Government Pivots to Back Pharma Industry Position in Proposed EU Reforms

(5/22, Jack Power, The Irish Times) ...Ireland had previously sat in a middle camp which supported attaching some conditions to the length of this period in a bid to improve access to new medicines in smaller and poorer EU states. Minister for Enterprise Peter Burke said the Government now supports the position pushed by the pharmaceutical industry that there should be no change. "We are prepared to accept eight years," he said in Brussels on Thursday... Full

Euro Convergence: Experts Emphasize Careful Planning for Market Launch Strategy

(5/21, Ferdous Al-Faruque, Regulatory Focus) ...While the US has more recently been viewed as the market of choice for medtech product launches, recent political and economic developments have led companies to reconsider which markets to target first. Experts advised manufacturers to consider factors such as investor needs, access to patients in clinical studies, and available regulatory pathways when deciding which markets to bring their products to, and in what order... Full

Poland Hits a Wall Trying to Curb Big Pharma's Profits

(5/22, Giedre Peseckyte, Politico) ...Senior diplomats from EU countries met in Brussels on Wednesday to discuss the position of the Polish presidency of the Council of the EU on the revamp of Europe's pharmaceutical legislation. But this first attempt to reach a Council agreement fell flat. Countries are split over the length of time that drugmakers' new medicines should benefit from market monopoly rights that keep competitors at bay... Full

Share of Generics in Russian Pharma Market Steadily Growing

(5/22, The Pharma Letter) ...According to the Russian research agency DSM Group, over the past six years, the share of localized generics on the Russian market has grown from 62% to 70% in volume terms. Thus, in 2024, their number amounted to 19,753 items, compared to 19,036 in 2018. According to Russian pharmacies, the biggest growth in sales of generic drugs in 2024 was observed in the segment of antidiabetic drugs (+118% in 2024). In value terms, the generics market in 2024 is estimated at approximately 1.2 trillion roubles ($14.7 billion), or about 50% of the pharmaceutical market as a whole... Sub. Req’d

What Stands in the Way of Biosimilar Use Across MENA Countries?

(5/21, Skylar Jeremias, The Center For Biosimilars) ...The adoption of generics and biosimilars in the MENA region remains limited despite their proven potential to reduce health care costs and improve access, largely due to inconsistent regulations, cultural resistance, and varying levels of acceptance among health care providers.2 While pharmacists are generally more supportive of generics, many physicians remain skeptical of both generics and biosimilars, citing concerns about efficacy, safety, and trust in local manufacturing... Full

Pharmexcil Urges Indian Pharma Companies to Tap into Saudi Arabia's Expanding Pharma Market

(5/22, Pharmabiz.com) ...The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has urged its member companies to actively participate in a virtual information session organized by the Ministry of Investment, Saudi Arabia (MISA) in coordination with the Embassy of India in Riyadh. Scheduled for June 23, 2025, the online event will focus on unlocking new business and investment opportunities between the two countries... Full

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