Thursday, April 10, 2025

Teva and Samsung Bioepis Launch Biosimilar Epysqli

(4/9, Skylar Jeremias, The Center For Biosimilars) ...Teva Pharmaceuticals and Samsung Bioepis have announced the US launch of Epysqli (eculizumab-aagh), a biosimilar to the blockbuster biologic Soliris (eculizumab), following FDA approval for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and generalized myasthenia gravis (gMG) in anti–acetylcholine receptor (AchR) antibody–positive adult patients... Full

Cheaper Soliris Biosimilars Reach the US Market

(4/10, Phil Taylor, Pharma Phorum) ...Amgen has priced Bkemv at a roughly 10% discount to Soliris, which has a list price in the US of $6,523 for a single-dose vial, while Teva has launched at a 30% discount – a difference that likely results from slightly different approval status for the two products at launch...Teva licensed rights to Epysqli in the US earlier this year and said that approximately 70% of eculizumab-treated PNH patients are not dosed according to the label, while two-thirds of patients discontinue eculizumab within an average of 1.5 years, which it claimed "can be attributed to several factors including the high treatment cost."... Full

Reuters Pharma Europe 2025: Access & AI Dominate Keynote Sessions

(4/9, Anne Smith, NAVLIN Daily) ...The final Wednesday morning keynote explored how to move from short-term experimentation to long-term implementation with various types of AI. "This is the inflection point," said Teva's Alyssa Fenoglio, Vice President, Global Head of Digital Commercial. "If you haven't already started, you're behind." She added, "It's not about waiting for your CEO to tell you what to do. The biggest barrier, but also the biggest key to success, is people."... Full

Russian Patients Call On State to Expand Public Procurements of Certain Vital Drugs

(4/10, The Pharma Letter) ...According to the VSP, it is important to expand this list by the inclusion of certain oncological and oncohematological drugs and at least genetically engineered biological drugs...To resolve the problem with the availability of such drugs, some regions independently announce auctions, however most of pharmaceutical companies do not participate in them either. According to the state register of drugs of Russia, medicines which contain glatiramer acetate in Russia have been registered by domestic companies Biocad, R-Pharm, Pharmasintez and Pharmmental Group, as well as Israel's Teva Pharmaceutical Industries, which originated the active ingredient and markets it as Copaxone... Sub. Req’d

Lupin Boosts UK Presence Through Renascience Acquisition

(4/9, Adam Zamecnik, Generics Bulletin) ...Lupin Healthcare has acquired the UK-based company Renascience Pharma for an undisclosed financial sum, further boosting its presence in the country while also adding four specialty products to its portfolio. The acquisition grants Lupin Healthcare, the UK-based subsidiary of the Indian pharma giant Lupin Limited, full ownership of Renascience. Renascience will continue to trade as Lupin Healthcare's local subsidiary... Global Sub. Full

Kabi Pens Agreement To Launch Generic Exparel In 2030 – With A Volume Limit

(4/10, Dean Rudge, Generics Bulletin) ...Fresenius Kabi is set to enjoy a 14-year jump on the US patents shielding Pacira BioSciences' Exparel (bupivacaine) liposomal injectable, albeit with a volume limit that will last for nearly a decade, under the terms of a patent-litigation settlement agreement that resolves all outstanding legal proceedings. Exparel brought in sales of $550m last year... Global Sub. Full

Biocon Biologics Gets USFDA Nod for Cancer Drug Jobevne

(4/10, The Hindu BusinessLine) ...Biocon Biologics, the biosimilar arm of Biocon has expanded its oncology portfolio with the USFDA approval of Jobevne, a cancer treatment drug...With this approval, Jobevne becomes the company's fourth oncology biosimilar in the US, adding to its existing portfolio that includes OGIVRI (trastuzumab), FULPHILA (pegfilgrastim), and ABEVMY (another bevacizumab biosimilar approved in other markets). Bevacizumab sales in the US stood at around $2 billion in 2023... Full

FDA Approves Injectable Antibiotics for B Braun Drug Delivery System

(4/10, Pharmaceutical Technology) ...The US Food and Drug Administration has approved the injectable antibiotics Piperacillin and Tazobactam for use in B Braun Medical's Duplex drug delivery system. The drug delivery system is a ready-to-activate container that separates pre-measured medication and diluent until activation by the provider during treatment... Full

Celltrion Scores Australian Approval for 3 Biosimilars in 2 Weeks

(4/10, Lee Han-soo, Korea Biomedical Review) ...Celltrion said it has received marketing approval from Australia's Therapeutic Goods Administration (TGA) for three new biosimilars — Eydenzelt (ingredient: aflibercept), an ophthalmology treatment, and Stoboclo and Osenvelt (ingredient: denosumab), targeting bone diseases... Full

Celltrion CEO's Blueprint: ADCs, Multispecific Antibodies

(4/9, Hong Sook, Korea Biomedical Review) ...Celltrion's expansion from biosimilars to novel therapeutics has taken a concrete step toward antibody-drug conjugates (ADCs) and multispecific antibodies. Beginning this year, the company has laid out a blueprint for clinical entry into these modalities. Celltrion's drug discovery business is led by CEO Seo Jin-seok, the eldest son of Chairman Seo Jung-jin. CEO Seo has outlined specific drug development goals at public events, including the recent shareholders' meeting and the JP Morgan Healthcare Conference... Full

AAN 2025: Competition Intensifying in Acute Migraine Space

(4/10, Clinical Trails Arena) ...At the American Academy of Neurology (AAN) 2025 annual meeting, held in San Diego, California from April 5, to April 9, 2025, acute treatments for migraine were a key topic, with several posters and presentations focusing on real-world use and comparative efficacy of different treatment options. Acute treatments are used to provide headache relief during a migraine episode, and the current treatment landscape is highly competitive... Full

Mapping the Vertical Integration of Insurers, PBMs, Specialty Pharmacies, and Providers: DCI's 2025 Update and Competitive Outlook

(4/9, Adam J. Fein, Ph.D., Drug Channels) ...Proponents of these vertical integration arrangements argue that they create opportunities to mine healthcare costs. However, these organizations remain highly controversial, due to the potential for anti-competitive behavior. We summarize some of the key issues below. While some major companies have narrowed their focus or unwound previous integration efforts, ongoing consolidation and selective deconsolidation will continue to reshape the healthcare biome by trying to build something epic, block by block... Full

Trump Pledges Tariffs On Pharmaceuticals, Setting Up Fight Over Who Pays

(4/10, Daniel Gilbert, The Washington Post) ..."If the tariff cost can be passed on to consumers, the pharmaceutical companies will happily do that," said Brad Setser, a senior fellow at the nonpartisan Council on Foreign Relations. But if insurers balk at paying higher prices as a result of tariffs, the drugmakers could have to absorb the costs themselves, largely undoing tax advantages they've reaped by moving their profits abroad, he said. "You could get a standoff," he said, as each side maneuvers for leverage. "If it leads to people being denied drugs because they can't afford them, that's a tragedy."... Sub. Req’d

Trump's Trade War: Prescription Drugs Become a Target

(4/10, Maggie Fick, Reuters) ...The timing is not certain, but on April 8 Trump said that the announcement on pharma tariffs would come "very shortly", without referencing Section 232. Creating further uncertainty, Trump on Wednesday said he would temporarily lower new tariffs on many countries, even as he raised them further on imports from China, in a sudden reversal that sent U.S. stocks sharply higher... Full

Trump Drug Tariffs Would Drive Up Prices, Worsen Shortages Before Any Boost to US Manufacturing, Experts Warn

(4/9, Meg Tirrell and Tami Luhby, CNN) ...Generic drugs, whether they're antibiotics, diabetes drugs or statins to lower cholesterol, sell for "pennies per dose," said Tom Kraus, vice president of government relations for the American Society of Health-System Pharmacists. Increasing the cost of ingredients that go into them "can make it so that it's no longer profitable to sell that drug in the United States."..."Added costs to already low-margin products may be a tipping point for companies to discontinue production," said Erin Fox, a drug shortages expert at University of Utah Health. "I'm worried we'll see discontinuation and a less resilient supply chain if companies quit making essential products."... Full

Global Pharma Stocks Tumble As Trump Vows Imminent Tariff Action

(4/9, Anna Bratulic, FirstWord PHARMA) ...Pharmaceutical stocks around the world took a sharp hit Wednesday as President Donald Trump's global tariffs went into effect, imposing import tax rates of 20% on the European Union, 24% on Japan, and a whopping 104% on goods from China...However, industry analysts are sceptical that pharmaceutical tariffs will trigger Trump's desired effect of boosting US manufacturing. "While the details are scant, we are strongly opposed to tariffs on any pharmaceuticals — these will likely do little to shift manufacturing back to the US," commented BMO Capital Markets analyst Evan Seigerman. "Given the complexity of the pharma supply chain, we do not expect the industry to make any major changes."... Sub. Req’d

Pharma Still Nervous While Riding Trump's Tariff Rollercoaster

(4/9, Jessica Merrill, Pink Sheet) ...What is ahead for pharmaceuticals is purely speculation. "What I can say is, with this 90-day hiatus and if this 10% ad valorem kind of thing is applicable, I think that will probably still shake up the markets, but not to the detriment of the system imploding," EY Americas Life Sciences Leader Arda Ural said in an interview with Pink Sheet sister publication Scrip. ZS Associates principal Howard Deutsch said the latest developments do not change pharma's position substantially... Global Sub. Full

Trump Says ‘Major' Tariffs On Pharmaceuticals Are Imminent, Manufacturing to Return to US

(4/9, Greg Slabodkin, Pharma Manufacturing) ...Testifying in a Tuesday hearing before the House Armed Services Committee, Sen. Todd Young (R-Ind.), chair of NSCEB, said biotech "will reshore supply chains and revitalize our manufacturing sector, creating American jobs for American workers creating American products here in our country." However, Jefferies analyst Michael Yee in a Tuesday note said investors are struggling to decide whether NSCEB's report — and any legislation that Congress might propose based on its recommendations — is good or bad for the U.S. biotech industry... Full

RFK Jr. Vowed to Upend American Health Care. It's Happening Faster Than Expected.

(4/9, Adam Cancryn, Politico) ......"It's a mess," said one former senior HHS official granted anonymity to discuss internal matters. "What was once a very robust place to work, that was trying to lead on innovation, is gone. It's just gone."... Full

Key Takeaways from RFK Jr.'s Interview On Measles Vaccine, Food Dyes, Weight Loss Drugs and More

(4/9, Sara Moriuszko, CBS News) ...GLP-1 agonists, which Kennedy called "extraordinary drugs," are available by prescription to anybody who's diagnosed as diabetic or pre-diabetic - but when pushed on whether they'd be covered by Medicare and Medicaid for those with obesity, Kennedy said officials are "looking at a regulatory framework." "Ideally over the long term, we'd like to see those drugs available for people after they try other interventions," Kennedy said. Those interventions, he said, include the use of glucose monitors and health regimens like a change in diet and exercise... Full

Drug Pricing Watchdog ICER Offers Ways to Increase Obesity Drug Access

(4/9, Zachary Brennan, Endpoints News) ...The Institute for Clinical and Economic Review, the nonprofit drug pricing watchdog, released a new report on Wednesday outlining potential federal policy solutions to increase access to blockbuster obesity drugs known as GLP-1s. The rise of GLP-1s has come with significantly increased costs for the federal government. Medicare Part D spending (before rebates) on GLP-1s went from $57 million in 2018 to $5.7 billion in 2022, ICER says... Full

ICER Lays Out GLP-1 Access Options In Addition To Medicare Coverage

(4/9, Luke Zarzecki, Inside Health Policy) ...The report also discusses the potential to test coverage through a Medicare demonstration managed by the Center for Medicare and Medicaid Innovation. ICER says this could be an effective way to generate evidence on longer-term outcomes in Medicare and Medicaid populations. "The CMMI would likely not have the authority to create its own version of narrower clinical eligibility criteria, but in principle it could design a model in which expanded coverage is linked to evaluation of longer-term clinical and economic outcomes, or to evaluation of combinations of drug treatment with different versions of lifestyle management," the report says... Sub. Req’d

The IRA Hurts Generic and Biosimilar Medication Competition

(4/10, AAM) ...Supporters of the "price negotiation" process established in the Inflation Reduction Act (IRA) claimed that it would not harm generic or biosimilar competition. They explained that the IRA's price negotiations would take effect only when a generic or biosimilar version of a drug is not available. However, they neglected to share, or failed to realize, that the law set up a process under which a drug would have price controls applied before a generic or biosimilar even had the chance to come to market. Two recent events drive this home and reveal that IRA price controls serve only to undermine lower-priced generics and biosimilars... Full

AAM: Drug Negotiations Inadvertently Favor Brand Biologics

(4/9, Maaisha Osman, Inside Health Policy) ...The Medicare drug price negotiation program may inadvertently favor expensive brand-name biologics over cheaper biosimilars, Craig Burton, executive director of the Biosimilars Council at the Association for Accessible Medicines, told House lawmakers Tuesday (April 8). Due to statutory coverage guarantees in the law, he said, Medicare plans will be required to cover reference biologics that went through negotiation -- even when lower-cost biosimilars are available... Sub. Req’d

E&C Punts SUPPORT Act Vote, GOP Rejects Dem's December Deal Revival

(4/9, Dorothy Mills-Gregg, Inside Health Policy) ...The House Energy & Commerce Committee adjourned its markup Tuesday (April 8) without voting on legislation to reauthorize the landmark law to address the opioid crisis, the SUPPORT Act, and committee Republicans rejected a proposal from Democrats to advance most portions of the bipartisan, bicameral health deal that stalled in December after Elon Musk nixed the broader spending bill it was part of... Sub. Req’d

New Medicare Negotiation Program ‘Iterations' Inevitable, Former CMS Official Blum Says

(4/9, Cathy Kelly, Pink Sheet) ...The Medicare price negotiation program will change in the future as policies like considering all versions of the same active moiety one product are reconsidered, former CMS principal deputy administrator Jonathan Blum predicted. CMS implemented the program under very tight timelines, which made conducting lengthy analyses on some policies unworkable, Blum said. The negotiation framework that the agency built will be "durable," but other elements of the program "feel more shaky" and will need more fleshing out, he said... Global Sub. Full

More On the Impact of the FDA RIFs: How Information Disclosure will Start FOIA-lling Behind

(4/10, Sarah Wicks and Anne K. Walsh, FDA Law Blog) ...Transparency has long been a cornerstone of FDA's public health mission, and one that the new HHS Secretary and FDA Commissioner have reinforced as their priorities. But in these unprecedented times, as the Agency navigates the strain of recent workforce reductions, the ripple effects are increasingly hard to ignore. What began as a staffing challenge is quickly becoming an information bottleneck—one that threatens to erode the transparency that stakeholders rely on... Full

Why the Closure of An FDA Office May Impact Generics Manufacturers — and Everyday Americans

(4/9, Ed Silverman, STAT+) ..."There are lot of nooks and crannies in the FDA that no one knows or thinks about, but they have an outsized role in generics," said Kurt Karst, a director at Hyman, Phelps & McNamara, a regulatory law firm, and co-founder of the FDA Law Blog, where he wrote about the demise of this FDA office. We spoke with Karst about the tasks that were handled by this office and what its loss will mean... Sub. Req’d

FDA Reverses Course On Telework After Layoffs and Resignations Threaten Basic Operations

(4/9, Matthew Perrone, Associated Press) ...It's the latest example of the Trump administration's chaotic approach to overhauling the federal health workforce, which has included firings, a scramble to rehire some employees, and then additional layoffs last week of an estimated 3,400 staffers, or more than 15% of the agency's workforce... Full

OMB Seeks Industry Input On Rescinding, Replacing Regs That Stifle Business, Ingenuity

(4/9, Dorothy Mills-Gregg, Inside Health Policy) ...The health care industry, among others, is being asked by the White House Office of Management and Budget to list which regulations it deems unnecessary, unlawful, unduly burdensome or unsound as the Trump administration looks to rescind or replace regulations that "stifle American businesses and American ingenuity." The unspecified stakeholders will have 30 days from Friday (April 11), when the request for information (RFI) is expected to be published in the Federal Register, to comment... Sub. Req’d

HHS Needs a Drug Shortage Plan, Watchdog Says

(4/10, Tina Reed, Axios) ...The Food and Drug Administration, as part of HHS, is responsible for tracking and addressing drug shortages in the U.S., the Government Accountability Office wrote in a report posted Wednesday. But "HHS did not have a coordinating structure across the department to oversee its responses and strategies," the GAO wrote, prompting the Biden administration in November 2023 to create a coordinator position within HHS to strengthen medical product supply chains and address related shortages... Full

Nebraska Governor Signs 340B Drug Pricing Protection Bill into Law

(4/9, Abigail Carrera, KOLN) ...Governor Jim Pillen signed LB 168, otherwise known as the 340B Contract Pharmacy Protection Act, into law at a signing ceremony on Wednesday. The bill, proposed by Sen. Brian Hardin of Scottsbluff and passed 42-5 on April 3, will prohibit 340B drug manufacturers from interfering with or denying the sale of such drugs to hospitals, clinics or pharmacies that manufacturers contract with... Full

Arkansas Legislature Passes Bill to Ban 'Monopoly' PBMs from Owning Pharmacies in State

(4/9, Andrew Mobley, KATV) ...Arkansas lawmakers in the Senate on Wednesday passed a bill that would stop pharmacy benefit managers from owning pharmacies and selling drugs retail in the state. The bill now heads to the governor's desk for her signature...If CVS chooses to continue operating as a PBM in Arkansas, it will have to close its pharmacies here. "All 23 stores, all of our CVS pharmacies would be shut down in 2026 and our hundreds of pharmacy colleagues would be displaced. They would be without jobs, myself included," said Ashley Ellis, CVS Health's district leader for pharmacy operations in Arkansas... Full

New Measures Cut Israel's Drug Approval Time To Just 70 Days

(4/9, Neena Brizmohun, Pink Sheet) ...Israel's drug regulator has introduced new measures to substantially cut the time it takes to register drugs in the country, for example, by shortening the time from 180 working days to just 70 days in certain cases. The measures, introduced under a new pilot project, involve a two-pronged approach that the Ministry of Health believes will expedite the availability of innovative medicines in Israel, lower operational costs, and consequently reduce prices, while ensuring compliance with safety and quality standards... Global Sub. Full

European Union to Put Countermeasures to U.S. Tariffs On Hold for 90 Days

(4/10, Jenni Reid, CNBC) ...On Wednesday, EU members voted in favor of the package, which was designed in response to the U.S. 25% tariffs on steel and aluminum launched last month. The duties were due to be finalized in the coming days, with an initial tranche set to come into effect on April 15. The full list of targeted items has not yet been published, though a draft document seen by CNBC in March listed products spanning clothing, poultry, grains, machinery and more... Full

Pulling Together: Global Regulators Discuss Convergence On Biosimilars

(4/9, Dave Wallace, Generics Bulletin) ...In this context, international collaboration is important, with EMA representatives recently indicating that it was an International Pharmaceutical Regulators Programme workshop that had "broken the ice" and helped the agency to move forward with its recent streamlining initiative... Global Sub. Full

Expected Budget Savings On Ustekinumab Biosimilars in Europe

(4/10, The Pharma Letter) ...South Korea's Samsung Bioepis presented data, including the budget impact analysis on ustekinumab biosimilars' cost savings in Germany, the UK and Sweden at the 8th International Meeting on Intestinal Diseases in conjunction with the Annual Congress of the Korean Association for the Study of Intestinal Diseases (IMKASID 2025) held in Seoul, Korea. Jeehoon Ghil, vice president and team leader of medical and lifecycle safety team at Samsung Bioepis, noted that the analyses "are pivotal for those considering biosimilars... Sub. Req’d

US Tariffs On Pharma: Dr Reddy's to Sun Pharma—Can Indian Drugmakers Escape Trump's Tariff Tantrums?

(4/9, Nikita Prasad, Mint) ...According to domestic brokerage Elara Securities (India) Pvt Ltd, a country-specific exemption for India is unlikely. If pharma tariffs were country-specific, there would have been no reason to hold them back when they were announced last week. Hence, analysts believe that a country-specific exemption for India is unlikely in the coming round of pharma tariffs... Full

DoP to Assign Agency to Develop Logistics Plan for Pharma & Medical Devices Sector

(4/10, Pharmabiz.com) ...The Department has invited Expression of Interest (EoI) applications from eligible agencies to conduct such a study, recognising that as one of the largest providers of generic drugs globally, India's ability to efficiently manage pharmaceutical logistics —directly affects its capability to deliver affordable and timely healthcare solutions worldwide... Full

U.S.-China Trade Dispute Expands to Biotech Sector, Prompting Strategic U.S. Response by Law

(4/10, Choi Mun-hee, Business Korea) ...If the Trump administration and the U.S. Congress proceed with imposing separate tariffs on pharmaceuticals and reintroduce the biosecurity law, Chinese companies dealing in raw pharmaceuticals and generics could face significant challenges. This could potentially block the business activities of Chinese companies within the U.S. bio industry. There is speculation that bio companies in other countries, such as Korea and Japan, could benefit if Chinese companies are restricted... Full

Big Pharma Drug Licensing from China Hits Record High

(4/9, The Pharma Letter) ...Licensing agreements for Chinese drug candidates hit a record high in 2024, with large pharma in-licensing 28% of innovator drugs from Chinese biopharma companies. Total deal values of innovator drug licensing agreements involving Chinese biopharma licensors surged 66%, from $16.6 billion in 2023 to $41.5 billion in 2024, marking a five-year high, according to pharma analytics company GlobalData... Sub. Req’d

Quality Considerations for Generic Drugs Entering the Chinese Market

(4/10, Lixue Zhang, MS, RAC, Regulatory Focus) ...This article explores the quality considerations for international generic pharmaceutical products launched in the Chinese market. It covers the fundamental principles of developing regulatory specifications, focusing on the stringent standards set by the Chinese Pharmacopoeia (ChP) for residual solvents, heavy metals, and ignition residue. It also discusses control strategies and limit-setting considerations for nitrosamine impurities. Understanding and addressing these challenges is pivotal for successful market entry... Full

New Medicines Pricing Proposals Would Mean More Uncertainty For Spanish Supply Chains

(4/9, Francesca Bruce, Pink Sheet) ...The associations are calling on the government to re-think the so-called "selected prices system" that would exacerbate already difficult conditions for the industry at a time of huge geopolitical instability. The associations behind the statement represent manufacturers of innovator medicines (Farmaindustria), orphan drugs (AELMHU), generic medicines (AESEG), biosimilars (BIOSIM) and non-prescription drugs (ANEFP) as well as AFAQUIM, which represent fine chemical manufacturers... Global Sub. Full

Russian Pharma Market Grew 10% to 2.85 Trillion Roubles in 2024

(4/9, The Pharma Letter) ...The Russian pharmaceutical market grew by 10% in value terms to 2.85 trillion roubles ($85 billion) in 2024, which was mainly due to the growth of it commercial segment, where the growth of sales was equivalent to 13.8%. At the same time the public procurements' segment demonstrated the by 2.6% sales' growth, being significantly below inflation rates in Russia, reports The Pharma Letter's local correspondent... Sub. Req’d

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