Monday, May 5, 2025

Teva, Alvotech Announce FDA Approval of Interchangeability for SELARSDI

(5/5, The Fly) ..."The FDA's confirmation of full interchangeability for SELARSDI is an important development for patients and providers seeking to expand access to this important treatment," said Thomas Rainey, Senior Vice President, U.S. Biosimilars at Teva. "Teva's recent launch of two biosimilars - SELARSDI and EPYSQLI - coupled with a rich pipeline of assets expected to launch over the next few years, position Teva to establish a strong leadership position in the growing landscape of biosimilars and to drive growth for the company as it embarks on the next phase of its strategy."... Full

Teva, Alvotech: FDA Approves Interchangeability for SELARSDI with Stelara

(5/5, The Fly) ...Alvotech manages development and manufacturing, while Teva is responsible for the exclusive commercialization in the U.S., leveraging its experience and extensive sales and marketing infrastructure. Two biosimilars developed under the Teva - Alvotech partnership have been granted FDA approval with interchangeability, including SELARSDI... Full

Direct Relief and TEVA Pharmaceuticals Donate $2.3 Million Medicines Health Facilities Across Ghana

(5/2, Francis Appiah, Modern Ghana) ...The donation is intended to boost healthcare delivery in underserved areas and relieve health institutions struggling with limited resources for procuring medication. The medicines were delivered on behalf of the two organizations by the management of Peace and Love Hospitals in Kumasi and Accra, led by Dr. Mrs. Beatrice Wiafe-Addai... Full

Seasonique Birth Control Recalled in Canada Over Missing Pills

(5/3, Katie Dangerfield, Global News) ...Health Canada is warning the public after one lot of Seasonique birth control pills was recalled across the country due to a packaging error that left two pills missing — a defect that could increase the risk of unintended pregnancy...Teva Canada Ltd., the manufacturer of Seasonique birth control pills, recalled the product after receiving a complaint that a package was missing two pills... Full

One Lot of Seasonique Birth Control Pills Recalled Due to Missing Pills

(5/3, Aarjavee Raaj, CTV News) ...Teva Canada Ltd., the manufacturer, recalled the prescription birth control pills after receiving a complaint that one of the packages was missing two pills, which the Friday recall notice notes may increase risks of pregnancy. "Missing a pill could lead to undesired pregnancy and other side effects, including spotting and irregular bleeding," the notice says...Health Canada says it is monitoring the company's recall and investigation, including the measures taken to prevent the problem from reoccurring... Full

Trump Says Drug Tariffs Are Coming. Big Pharma Execs Can't Figure Out How Much to Worry.

(5/2, Josh Nathan-Kazis, Barron's) ...One optimist is Pfizer chief Albert Bourla, who also serves as chair of the board of the drug industry lobbying group PhRMA. Bourla said on an investor call Wednesday that he is "cautiously optimistic" after having conversations with "all the Secretaries that are involved and the White House staff."...Thursday morning, though, Eli Lilly CEO David Ricks pulled expectations back down to earth. Speaking to Barron's before the market opened, Ricks called Bourla's optimism "a little early." "Maybe he knows something I don't," Ricks said... Full

Biocon Secures Multiple Market Access Agreements for Yesintek

(5/5, CNBC TV-18) ...Biocon Ltd. on Monday, May 5, said its subsidiary Biocon Biologics has secured multiple market access agreements for Yesintek, its biosimilar to Stelara. The market access agreements from numerous plans represent over 100 million lives in the US...Additionally, Yesintek has been selected as the exclusive Ustekinumab by Blue Cross Blue Shield of Michigan (BCBSM), Florida Healthcare Plan, and several closed-door health systems... Full

Amgen's Stelara biosimilar Gets Off to Fast Start

(5/2, Jonathan Gardner, BioPharma Dive) ...Amgen is nearly alone among its large drugmaker peers in committing to biosimilar drugs. But its decision has helped bolster revenues at a time when its own branded products are facing pressure from lookalike biologics. Amgen's investment in biosimilars isn't slowing down, either. The company has in Phase 3 trials competitors to the checkpoint inhibitors that revolutionized cancer care over the past decade. The two top sellers, Bristol Myers Squibb's Opdivo and Merck & Co.'s Keytruda, are due to lose patent protection in 2028, though subcutaneous versions of those drugs may complicate Amgen's plans... Full

Amgen's Aflibercept Starts Strong As Regeneron Counts Cost Of Eylea Competition

(5/2, Dean Rudge, Generics Bulletin) ...Amgen's Pavblu (aflibercept-ayyh) 2mg biosimilar achieved revenues of $99m in its first full quarter on the market. The biosimilar has just received its permanent reimbursement Q code, facilitating access for patients. Regeneron's management has insisted that the overall size of the branded anti-VEGF category had contracted in the first quarter, compounding the headwind it faces from biosimilar competition... Global Sub. Full

Lupin Touts FDA Approval For Generic Tolvaptan With 180-Day Exclusivity

(5/2, Urte Fultinaviciute, Generics Bulletin) ...Lupin was granted a 180-day generic drug exclusivity for the generic version of Jynarque (tolvaptan). The drug will be launched soon and is expected to be a growth driver for Lupin in FY2026. The FDA also cleared the Nagpur-based injectables plant used for drug-medical device combination products... Global Sub. Full

Sandoz Slims Down Pembrolizumab Trial As Regulators Streamline Requirements

(5/2, Dave Wallace, Generics Bulletin) ...Sandoz has announced plans to slim down and "minimize" its current Phase III trial for a biosimilar version of Keytruda (pembrolizumab). The decision comes after discussion with the US FDA as well as in the wake of recent moves from international regulators such as the EMA to streamline requirements for biosimilars. Sandoz said it was also assessing the implications of these regulatory developments for its wider biosimilars pipeline... Global Sub. Full

Out-Of-Pocket Drug Spending Hit $98B in 2024: Report

(5/5, Maya Goldman, Axios) ...Net spending on medicine rose 11.4% in 2024 to $487 billion. Prescription costs on average were flat compared with 2023, but there was greater use of medicines with significant clinical benefits, IQVIA said. More than one-quarter of new prescriptions were not filled in 2024, mostly because they aren't covered by insurers. Payer rejections may be driven by factors like prior authorization requirements or formulary decisions, but nearly half of those rejections are overcome either by the patient switching to a secondary insurer, paying cash, or adding a coupon, per IQVIA... Full

Drug Price Negotiation Outreach, Education Funds Chopped In HHS Budget Request

(5/2, Gabrielle Wanneh, Inside Health Policy) ...The Trump administration wants to eliminate education and outreach directed at those not directly involved in Medicare drug price negotiations as part of a broader fiscal 2026 budget request that proposes slashing over half a billion dollars from myriad CMS programs and operations the administration says have been carrying out "non-statutory, wasteful, and woke activities."... Sub. Req’d

Trump Revives Most Favored Nation Plan, But Only For Medicaid

(5/2, Maaisha Osman, Inside Health Policy) ...The Trump administration is urging congressional Republicans to include a "most favored nation" (MFN) policy in their domestic policy package that would tie Medicaid drug payments to the lowest prices paid in other wealthy countries, a White House official confirmed to Inside Health Policy. But consumer advocacy group Public Citizen warns the move would generate far less savings than applying the same policy to Medicare... Sub. Req’d

Trump's HHS to Provide Additional Guidance On Drug Rebate Model

(5/2, Nyah Phengsitthy, Bloomberg Law) ..."Because the implications are not straightforward, the Department of Health and Human Services continues to carefully evaluate its options alongside ongoing efforts to address 340B program integrity matters and keeping in mind the approaching effective date of certain Inflation Reduction Act requirements," the Department of Justice wrote for HHS. The HHS expects to be in a position to provide guidance for stakeholders in 30 days, according to the notice... Sub. Req’d

Drug Tariffs Could Boost 340B Discounts—and Scrutiny

(5/2, Alex Kacik, Modern Healthcare) ...Under a potential tariff policy, drugmakers would have to pay more for pharmaceutical ingredients, many of which are sourced from China and India, possibly resulting in higher production costs and drug prices. If drug prices rise, hospitals eligible for discounted drugs could generate more savings through the federal 340B drug pricing program, legal and policy experts said... Sub. Req’d

Trump Seeks to Squeeze Drugmakers' Revenues to Pay for Tax Cuts

(5/2, Rachel Cohrs Zhang, Bloomberg) ...While the pharmaceutical industry has notched some wins with temporary relief on tariffs and an industry-friendly provision in a recent executive order, Trump's revival of his policy idea executives most dislike is bad news. "Government price setting in any form is bad for American patients... At a time when we are facing growing competition from China, policymakers should focus on fixing the flaws in the U.S. system, not importing failed policies from abroad," PhRMA spokesperson Alex Schriver said in a written statement... Full

Don't Punish PBMs for Pharma's Pricing Problem

(5/5, Ike Brannon, RealClearMarkets) ...If policymakers genuinely seek to lower prescription drug prices and protect consumers, the solution is not to disrupt efficient, integrated pharmacy services but to enhance competition among drug manufacturers by reforming the FDA's regulatory pathways. PBMs—armed with more competitive drug offerings—can then do precisely what they were designed to do: drive down drug costs through robust negotiation, streamlined distribution, and increased efficiency... Full

Biotech Companies Tell Cassidy FDA RIF Leaves Agency Overwhelmed

(5/2, Jessica Karins, Inside Health Policy) ..."While we share a desire to strengthen and modernize the FDA, we are writing to share that we are deeply concerned about the current state of the agency and its future," they wrote. "Specifically, we worry that the institutional knowledge that makes the FDA the world's leading regulatory body will be irretrievably lost due to the agency's recent reduction in force and wave of retirements. The agency's ability to function is compounded by a hiring freeze. As a result, American patients, American industry, and American biomedical leadership will bear the consequences."... Sub. Req’d

Exclusive: US FDA Asks Some Fired Pharma User Fee Negotiation Staff to Return

(5/2, Patrick Wingrove, Reuters) ...The U.S. Food and Drug Administration is asking some of its recently fired staff responsible for critically important funding negotiations with drugmakers to return, three sources close to the matter said. The staff being asked back are involved with renewing programs under which drugmakers provide user fees that pay for the agency's drug review system... Full

Exclusive: After FDA Firings, Drug Reviewers Are Asked to Volunteer for Administrative Work

(5/2, Zachary Brennan, Endpoints News) ...The email from the Office of New Drugs leadership, which was reviewed by Endpoints News, said that the FDA's Center for Drug Evaluation and Research "is still working on a long-term solution for our timekeeping needs," referring to the process of tracking and processing FDA staffers' hours and verifying that they're correct. "If folks are willing to be trained to be a timekeeper or have prior timekeeping experience (does not need to be recent), please respond back," said the email, which was sent from "OND Exec Ops" to a list called "CDER-OND-ALL."... Sub. Req’d

Makary's Reorganization Decision A Turning Point For US FDA?

(5/2, Michael McCaughan, Pink Sheet) ...Commissioner Martin Makary's rejection of a proposed major FDA reorganization finally may be a step in the right direction for FDA staff after weeks of upheaval. Stakeholders now may begin to wonder whether agency staff can calm down and adjust to the new normal. Preventing further damage may not improve morale, but more importantly will not lower it further... Global Sub. Full

Express Scripts Controls Nearly 90% of PBM Market in Michigan, New Lawsuit Says

(5/2, Noah Tong, Fierce Healthcare) ...The state of Michigan has sued pharmacy benefit managers Express Scripts and Prime Therapeutics for anticompetitive behavior and suppression of reimbursement rates to independent pharmacies. Michigan Attorney General Dana Nessel argues an agreement between the two PBMs helped foster pharmacy deserts across the state and violated antitrust laws. Half of Detroit's neighborhoods are classified as pharmacy deserts (PDF), the lawsuit claims... Full

How Donald Trump's Tariffs Threaten Canadians' Access to Prescription Drugs

(5/4, Joel Lexchin, The Conversation) ...If the United States imposes 25 per cent tariffs on exports from Canada, nearly all economists agree a recession is inevitable. Estimates are that between 600,000 to 2.4 million jobs are at risk...Canada already imports $8.76 billion annually in prescription drugs from the U.S. To the extent that tariffed drugs go from China to the U.S. to Canada, the cost of both publicly and privately funded drug plans will increase. Those people at the bottom of the income scale who pay out-of-pocket — and can least afford to pay more — will be saddled with those higher prices. If Canada follows the U.S. in imposing tariffs on drugs made in China, as we have done with electric vehicles, then the price of generic drugs made in Canada from Chinese ingredients will also rise... Full

Competition Bureau Probes Drug Makers' Rebate Payments to Express Scripts Canada

(5/4, Chris Hannay and Clare O'Hara, The Globe and Mail) ...The Competition Bureau has requested information from Express Scripts Canada, one of the largest processors of insurance claims at pharmacy checkouts, about how much it is receiving in rebates from drug manufacturers, according to court filings...The bureau's application to Federal Court, which The Globe and Mail obtained from the courthouse, specifies the information it is seeking from Express Scripts, including a request for interviews with four executives. Among the data the bureau is seeking is information about what rebates Express Scripts received from drug manufacturers, drug wholesalers or pharmacies as part of its business arrangements... Full

Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

(5/2, Eliza Slawther, Pink Sheet) ...Swissmedic, the Federal Office of Public Health and the Association of Cantonal Pharmacists have agreed on temporary measures to ease shortages of medicines. The regulator said that by expanding the interpretation of the term "emergency," health care professionals will be able to import medicines in acute shortage situations. It said this would be particularly beneficial for pediatric medicines, which are susceptible to shortages... Global Sub. Full

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