Tuesday, May 6, 2025

Teva Jumps On FDA Approval for Biosimilar

(5/5, Shiri Habib-Valdhorn, Globes) ...The FDA has ruled that SELARSDI, which Teva has launched with Alvotech, is interchangeable with Stelara for treating adult and pediatric psoriatic arthritis and plaque psoriasis, as well as Crohn's disease, and ulcerative colitis... Full

FDA Approves Teva-Alvotech Biosimilar Selarsdi for Multiple Conditions

(5/6, Swagath Bandhakavi, World Pharmaceutical Frontiers) ...This approval allows Selarsdi to be used across all its approved indications, including adult and paediatric psoriatic arthritis, plaque psoriasis, Crohn's disease, and ulcerative colitis. Teva US biosimilars senior vice president Thomas Rainey said: "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."... Full

FDA Approves Selarsdi Injection as Interchangeable with Stelara

(5/6, Pharmaceutical Technology) ...Including Selarsdi, the companies have seen two biosimilars developed by them gain US regulatory approval with interchangeability. Alvotech and Teva noted that they have three additional biosimilar candidates under review by the US regulator: a proposed biosimilar for Simponi (golimumab) and Simponi Aria (golimumab), AVT05, and AVT06, which is a proposed biosimilar for Eylea (aflibercept)... Full

FDA Approves Interchangeability Designation for Teva and Alvotech's Stelara Biosimilar Selarsdi for Multiple Indications

(5/5, Don Tracy, PharmExec.com) ...The FDA has approved Teva's and Alvotech's Selarsdi (ustekinumab-aekn) as a fully interchangeable biosimilar to Stelara (ustekinumab). Selarsdi's indications include adult and pediatric psoriatic arthritis (PsA) and plaque psoriasis, as well as Crohn disease and ulcerative colitis. The approval covers doses of 45 mg/0.5 mL and 90 mg/mL administered in a single-dose prefilled syringe for subcutaneous injection and 130 mg/26 mL in a single-dose vial for intravenous (IV) infusion... Full

Ustekinumab-Aekn Now Interchangeable With Reference for PsA, PsO, CD, UC

(5/5, Victoria Johnson, HCPLive) ...Teva and Alvotech are expanding their biosimilar portfolio, with Selarsdi being their second U.S. market biosimilar, aiming to reduce healthcare costs. Ustekinumab-aekn is produced using the same host cell line and process as the reference product, ensuring treatment consistency and efficacy... Full

Biosimilar Selarsdi Now Interchangeable With Stelara

(5/5, Jaymin Kang, PharmD, MPR) ...Selarsdi can now be substituted for the reference product without requiring a prescription change. The substitution may occur at the pharmacy similar to how generics are substituted for brand name drugs. The product is currently available and interchangeable in all presentations matching the reference product... Full

FDA Nod for Interchangeability of Selarsdi with Stelara

(5/5, The Pharma Letter) ..."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," [Thomas Rainey, senior vice president, US Biosimilars at Teva] noted... Sub. Req’d

6 Drugs in Shortage

(5/5, Alexandra Murphy, Becker's Hospital Review) ...Doxycycline hyclate tablet: Teva Pharmaceuticals has discontinued two 100 mg tablet presentations of doxycycline Hyclate, an antibiotic used to treat bacterial infections including respiratory tract infections, acne and certain sexually transmitted diseases. Drospirenone; ethinyl estradiol tablet: Teva Pharmaceuticals has discontinued Ocella, a combination oral contraceptive used to prevent pregnancy. No resupply date was announced... Full

Tofidence And Tariffs - Organon Discusses Exposure Of Its Biosimilars Business

(5/6, Dave Wallace, Generics Bulletin) ...Acknowledging "a lot of uncertainty in the broader market" around current and future tariff policy, [Organon CEO Kevin] Ali reassured that "based on tariffs in place as of today, we have very limited exposure in 2025." For the US biosimilars business, Organon's Samsung Bioepis-partnered Ontruzant (trastuzumab-dttb), Renflexis (infliximab-abda) and Hadlima (adalimumab-bwwd) were "mainly supplied from Korea and the EU," he noted... Global Sub. Full

Bristol Myers to Invest $40 Billion in the US Over 5 Years

(5/5, Christy Santhosh, Reuters) ...The announcement of new investment was first made by CEO Christopher Boerner in an opinion piece published in Stat News on Monday, and was later confirmed to Reuters by a company spokesperson. In the Op-Ed, Boerner said the money will be spread across research and development, technology and domestic manufacturing, as U.S. drugmakers prepare to deal with Trump's tariffs...Boerner said bolstering U.S. manufacturing enables greater control over highly complex supply chains while bringing manufacturing closer to where the majority of R&D is taking place... Full

India's Alembic Pharma's Quarterly Profit Drops On Tax Expense

(5/6, Kashish Tandon, Reuters) ...Indian drugmaker Alembic Pharmaceuticals reported a 12% fall in fourth-quarter profit on Tuesday, hurt by a deferred tax expense that offset the impact of strong sales in its key U.S. and domestic markets...A large chunk of revenues for most Indian generic drugmakers comes from the U.S. While fierce competition in North America's generic drugs market has been weighing on some firms' margins, generic drugmakers are also under threat from U.S. President Donald Trump tariff plans for the sector... Full

Senores Inks Deal to Acquire Wockhardt's ANDA for Topiramate

(5/5, Business Standard) ...Senores Pharmaceuticals, through its wholly-owned subsidiary Senores Pharmaceuticals, Inc., USA, has signed agreement today to acquire the USFDA-approved Abbreviated New Drug Application for Topiramate HCl 25, 50, 100 and 200 mg tablets (Topiramate) from Wockhardt... Full

Glenmark Pharma's Relapsed Cancer Drug Gets FDA 'Fast Track' Status

(5/5, Jomy Jos Pullokaran, CNBC TV-18) ...Pharma major Glenmark Pharmaceuticals Ltd on Monday (April 5) said its innovation arm, Ichnos Glenmark Innovation (IGI), announced that the US Food and Drug Administration has granted ‘fast track' designation to ISB 2001, its investigational therapy for multiple myeloma. The designation is specifically for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody... Full

Adalvo And Gedeon Richter Join Forces On Semaglutide

(5/6, Dave Wallace, Generics Bulletin) ...Adalvo and Gedeon Richter have signed a global co-development deal for semaglutide for obesity. Initial commercialization efforts will focus on "high-potential" regions including the US, Canada, and the EU. Adalvo is also leading an advanced development program for an oral version of semaglutide. Both firms are open to exploring further opportunities in the injectable GLP-1 space as part of a longer-term strategic partnership... Global Sub. Full

Vertex Says 20,000 Prescriptions Filled for Non-Opioid Pain Drug

(5/5, Gerry Smith, Bloomberg) ...Vertex Pharmaceuticals Inc. said more than 20,000 prescriptions have been dispensed for its new non-addictive painkiller, a sign that the drug is gaining some early traction as it attempts to displace opioids...BMO Capital Markets analyst Evan Seigerman called the early numbers "a good start," but he noted that the company appears to be giving much of the drug away for free while it secures wider insurance coverage. Seigerman doesn't expect much revenue from Journavx this quarter or next... Sub. Req’d

Viatris Agrees To $335M Opioid Settlement Ending US State, Local Government Cases

(5/5, Dean Rudge, Pink Sheet) ...Viatris reached an agreement to settle nationwide opioid marketing and other claims from US states and local governments for $335m, but admitted no wrongdoing. The company will pay the amount over nine years, depending on the level of participation in the settlement. Multiple companies, as well as Purdue Pharma owner the Sackler family, have reached settlements of opioid claims... Global Sub. Full

Federal Circuit Keeps FDA Hold in MSN-Novartis Drug-Patent Fight

(5/5, Christopher Yasiejko, Bloomberg Law) ...The generic-drug maker is appealing rulings that block the early launch of its copy of the blockbuster heart-disease drug and preserve Novartis' market exclusivity until a patent's pediatric exclusivity expires in July. The US Court of Appeals for the Federal Circuit on May 2 ordered the district court to keep its temporary stay in effect as the appellate judges consider MSN's request for a pause while the now-consolidated appeals continue... Sub. Req’d

Trump Signals An Announcement On Medicine Costs Coming Next Week

(5/6, Reuters) ...President Donald Trump said on Monday he will make an announcement next week on the costs of medicines... Full

Trump Signs Order to Boost Domestic Drug Manufacturing as Pharma Tariffs Loom

(5/5, Annika Kim Constantino, CNBC) ...The order directs the Food and Drug Administration to reduce the amount of time it takes to approve manufacturing plants in the U.S. by eliminating unnecessary requirements, streamlining reviews and working with domestic drugmakers to "provide early support before facilities come online," according to a White House fact sheet... Full

Trump Signs Order in Bid to Boost Pharma Manufacturing in the U.S.

(5/5, Ed Silverman, STAT+) ...In a statement announcing the executive order, the White House noted estimates suggest that building new manufacturing capacity for pharmaceuticals may take as long as five to 10 years, which it called "unacceptable from a national-security standpoint. This order will speed up timelines for building domestic pharmaceutical manufacturing site by reducing regulatory barriers to construction." In a statement, President Trump said that "we don't want to be buying our pharmaceuticals from other countries because if we're in a war, we're in a problem, we want to be able to make our own. As we invest in the future, we will permanently bring our medical supply chains back home. We will produce our medical supplies, pharmaceuticals, and treatments right here in the United States."... Sub. Req’d

Americans Would Suffer Most if Trump Imposes Pharma Tariffs, Sector Warns

(5/5, Julia Kollewe, The Guardian) ...Americans would suffer most if Donald Trump imposed tariffs on imports of pharmaceuticals, as medications would become more expensive and potentially unaffordable for some people, drugmakers have warned...Giovanni Barbella, the global head of strategy and supply chain at the Swiss multinational Sandoz, said tariffs would lead to supply disruptions and in the medium term price increases, hitting US patients hardest. Sandoz is one of the world's biggest makers of generic drugs – cheaper versions of branded medicines whose patents have expired. The majority of prescription drugs sold around the world are generic... Full

Pharma Predicts Modest Tariff Impact, Depending On What Comes Next

(5/5, Jessica Merrill, Pink Sheet) ...Drug manufacturers and investors want more detail on US government plans for pharmaceutical-sector tariffs. Pharmaceutical companies appear confident they can absorb the impact of broader tariffs this year, but the predictions do not include pharma-specific tariffs. A PhRMA-sponsored report concludes a 25% tariff on pharmaceutical imports would increase the cost of imported pharmaceuticals $50.8bn annually... Global Sub. Full

How to Stop the Shift of Drug Discovery from the U.S. to China

(5/6, Scott Gottlib, STAT) ...This shift of discovery work to China is going to accelerate if we don't take deliberate steps to make it easier to do such work here in America. Yet the imperative to modernize early-stage drug development - to ensure that groundbreaking drug discovery remains in the U.S. rather than migrating to China - is colliding head-on with an impulse to slash the very government workforce capable of spearheading these reforms... Full

Bipartisan Senators Offer New Bill Aimed at Lowering Drug Prices

(5/5, Nathaniel Weixel, The Hill) ...The bill from Sens. Josh Hawley (R-Mo.) and Peter Welch (D-Vt.) is a riff on the "most favored nation" policy President Trump pushed in his first term, which tried to tie domestic prices for certain prescription drugs in Medicare to the lowest level paid by comparable countries. Drug companies sued shortly after the effort was launched as an interim final rule, and it was blocked in federal court... Full

Conservatives Must Resist the Temptation of European Drug Price Controls

(5/5, Ryan Ellis, RealClearHealth) ...Republicans should reject MFN pricing and embrace the stronger, market-based alternative to trim Medicaid spending. Reform should reward innovation, not punish it... Full

NCL Calls For FTC, FDA Action To Stem Use Of Unapproved GLP-1s

(5/5, Luke Zarzecki, Inside Health Policy) ...A new white paper from the National Consumers League (NCL) floats ways to weed out the growing use of unapproved weight-loss drugs from legitimate products -- calling for reimbursement of FDA-approved versions, stepped up enforcement by FDA against unapproved compounding and a potential new role by the Federal Trade Commission to stop misleading advertising by unapproved online providers... Sub. Req’d

Experts: Maintain Inspection Readiness Despite Recent Upheaval at FDA

(5/5, Joanne S. Eglovitch, Regulatory Focus) ...Pharmaceutical and medical device manufacturers should not assume that recent staff cuts at the US Food and Drug Administration (FDA) mean the agency will inspect less often and take fewer enforcement actions, according to a panel of experts who spoke at a Food and Drug Law Institute (FDLI) webinar on May 1... Full

Governor Youngkin Signs Bill to Protect Local Pharmacies in Virginia

(5/5, Kathleen Lundy, 13 News Now) ...Governor Glenn Youngkin has signed into law a bill that creates a single pharmacy benefit manager for the state's Medicaid program. The legislation, part of the Save Local Pharmacies Act, will take effect on July 1, 2025. The move follows a broader effort to rein in the influence of PBMs, which are third-party companies that negotiate drug prices between manufacturers and insurers. Some of the largest PBMs, including Caremark (CVS Health), Express Scripts (Cigna), and OptumRx (UnitedHealth Group), also own pharmacies, a practice critics say creates a conflict of interest... Full

Medicines UK Welcomes NHS England's Best-Value Biologics Biosimilar Adoption Framework

(5/6, Adam Zamecnik, Generics Bulletin) ...NHS England selected five biological medicines nearing patent protection expirations, including Eylea and Stelara. 100% of new patients and 80% of current patients will switch to best-value biological medicines within months after their launch. Medicines UK also pointed out additional undisclosed higher value biologics, which are nearing patent expiry. Medicines UK also welcomed the MHRA's decision to grant biosimilar licenses within 150 days... Global Sub. Full

EU Needs Pharma Production Incentives to Fight US Tariffs, Says Czech Official

(5/6, Aneta Zachová, Euractiv) ...Amid escalating trade tensions and the prospect of US tariffs on pharmaceuticals, Europe must encourage pharmaceutical companies to maintain their research and manufacturing operations within the EU, Czech Deputy Health Minister Jakub Dvorácek told Euractiv... Full

‘Change Course On EU Medicines Act Revisions' Dutch Pharma Association Urges Government

(5/6, Christoph Schwaiger, Euractiv) ...The Dutch innovative medicines association, VIG, has urged the Dutch government to change its position on the revision of the EU's pharmaceutical legislation, claiming the current plans will have disastrous consequences for the country... Full

India Offers Zero-For-Zero Tariffs On Auto Parts, Steel from US

(5/5, Shruti Srivastava and Mihir Mishra, Bloomberg) ...India has proposed eliminating tariffs on steel, auto components, and pharmaceuticals for a specific import quantity in trade negotiations with the US. Beyond that threshold, standard duties would apply. This offer aims to expedite a bilateral trade deal expected by fall, prioritizing certain sectors before the end of the US tariff pause... Full

Korean Firms 'Exploring Options' as Trump's Pharma Tariffs Loom

(5/6, Hwang Soo-Yeon, Korea JoongAng Daily) ...In Korea, the companies most at risk include new drug developers and contract development and manufacturing organizations (CDMO) that export heavily to the United States. Korean pharmaceutical exports to the United States totaled $3.98 billion last year, according to the Korea Biotechnology Industry Organization. Samsung Biologics, a leading CDMO based in Songdo, Incheon, supplies 17 of the world's top 20 pharmaceutical companies...However, analysts say the tariff impact on Samsung Biologics could be limited, as most of its exports involve drug substances rather than finished products. Even if tariffs apply to active pharmaceutical ingredients, they account for less than 10 percent of the final drug price, Shinyoung Securities analyst Jung Yoo-kyung wrote a recent report. "The impact on client profitability is minimal, and the chance of customers demanding price cuts is low," Jung noted... Full

Korea's Pharmaceutical Exports Set to Top $10 Bn, Led by ‘K-M7' Champions

(5/5, Tae-Ho Lee and Dae-Hun Kim, The Korea Economic Daily) ...South Korea's pharmaceutical exports are on course to surpass $10 billion this year, underscoring the country's growing clout in the global biotechnology market as companies like Samsung Biologics Co. and Celltrion Inc. extend their international reach. According to the Ministry of Trade, Industry and Energy, exports of pharmaceutical products between January and April reached $3.62 billion, a 17.7% increase from the same period a year earlier... Full

Note: Article links may expire over time or require a free registration. All news articles are the property of their respective publishers and copyright holders. [contextual emphasis added].

Teva global subscription access: registration is required to access FirstWord Pharma+ News and The Generics Bulletin. Please note you must be on the Teva Network (in a Teva location or connected via VPN) to access Teva's InfoNOW news resources. If you have any questions or issues, please email InfoNOW@tevapharm.com.

 

•      FirstWord Pharma+ News registration: first-time users, register here with your Teva email address. You will automatically receive a daily FirstWord Pharma+ newsletter; click on any news item to access your account.

•      Generics Bulletin, Pink Sheet, Scrip (Citeline) registration: go to the Generics Bulletin site and choose "Sign In" in the upper right-hand corner. First-time users, choose "Sign Up Here" and enter your Teva email address.