Wednesday, April 1, 2026

 

 

Teva's Prolia Biosimilar Approved By US FDA As Xolair Rival Filings Accepted In EU And US

(4/1, Urte Fultinaviciute, Generics Bulletin) ...To be marketed under the name Ponlimsi, the biosimilar is indicated for all bone conditions covered by the reference product. Calling it a "significant milestone," Yolanda Tibbe, Teva's global head of biosimilars, said that the approval showcases the firm's robust clinical, analytical, operational, and regulatory expertise... Sub. Req’d

 

Teva Receives FDA Approval for Prolia Biosimilar

(3/31, Salong Debbarma, Pharmaceutical Technology) ...Teva biosimilars R&D head and chief science officer Steffen Nock said: "Our biosimilars R&D engine continues to demonstrate its depth and maturity. By combining deep internal expertise with strategic partnerships, we're building a highly competitive portfolio. "With a strong early-stage pipeline and a suite of advancing programmes, we see significant potential to address patient needs and fuel Teva's long-term growth."... Full

 

FDA Approves Teva Biosimilar for Denosumab in Osteoporosis

(3/31, Sabrina McCrear, The Center for Biosimilars) ...Additionally, Teva's applications for a proposed biosimilar to the reference product Xolair (omalizumab; Novartis AG) were accepted by the US FDA and the European Medicines Agency to treat allergic asthma... Full

 

Fosun Pharma and Teva's Co-Developed Innovative Anti-Tumor Immunotherapy Drug FXB0871 Approved for Phase 1 Clinical Trial in China

(3/31, Fosun Pharma) ...FXB0871 (referred to as TEV-56278 outside of Fosun Pharma territory) is an anti-PD1-IL2 ATTENUKINE™ therapy being co-developed by Fosun Pharma and Teva Pharmaceutical Industries Ltd.. The Teva-developed ATTENUKINE technology provides a new mechanism of action, potentially offering high efficacy and low toxicity in a broad array of oncology indications. It is being evaluated as a monotherapy across a variety of tumor types. Pre-clinical data has demonstrated tumor regression, enhanced T-cell infiltration, and durable immune memory... Full

 

 

Trump's MFN Pricing Expected To Delay More European Drug Launches

(4/1, Nick Paul Taylor, BioSpace) ...If the Trump administration pushes ahead with its proposed MFN models, drugmakers will need to either accept lower prices in the U.S., persuade reference countries in the EU and other regions to pay more or restrict where they launch medicines. Majewski described the situation as a "game of chicken." Unless someone backs down, Majewski said some drugs might not reach the EU in "the short-ish term."... Full

 

Two Months Later, Success of TrumpRx Is Mixed: Are Lower Prices Really Available?

(3/31, Julia Bonavitacola, AJMC) ...[Benjamin Rome, MD, MPH, an associate physician in the Division of General Internal Medicine and Primary Care at Brigham and Women's Hospital] compared the legislation in the Inflation Reduction Act having staying power over 2 administrations vs the potential result of TrumpRx when the Trump administration is no longer in power, saying, "Ultimately the biggest limitation of many of the steps the Trump administration is taking to lower prescription drug prices is the reliance on executive actions and handshake deals that may not stand the test of time."... Full

 

Public Opinion on Prescription Drugs and Their Prices

(3/31, Audrey Kearney, Julian Montalvo III, Ashley Kirzinger, and Liz Hamel, KFF) ...Despite seeing their general benefits to society, about eight in ten adults (82%) say the cost of prescription drugs is unreasonable, and the public sees profits made by pharmaceutical companies as the largest factor contributing to these prices. More than three-quarters of adults across partisanship say profits made by pharmaceutical companies are a "major factor" in the price of prescription drugs... Full

 

Matsui Unveils Bipartisan Bill to Lower Prescription Drug Costs for Seniors

(3/31, Congresswoman Doris Matsui) ...The Ensuring Access to Lower-Cost Medicines for Seniors Act would help change that by requiring Medicare Part D plans that cover these lower-cost products to place them in a preferred position relative to the higher-cost reference drug or biologic, when they are cheaper. The bill ensures that when a lower-cost medicine is available, seniors can actually get it at a lower cost... Full

 

What Potential Fallout Will MFN Policies Have?

(4/1, Mike Hollan, PharmExec.com) ...Lindsay Bealor Greenleaf, head of market access policy strategy at ADVI, spoke with Pharmaceutical Executive about the current state of MFN and how the industry expects it to impact operations as more of the policies come online... Full

 

MFN Dealmaker Exemption From GLOBE, GUARD Models Needs Separate Rulemaking, CMS Told

(3/31, Cathy Kelly, Pink Sheet) ..."The proposed inclusion and exclusion criteria for the models and the associated comment solicitations do not offer the signing of a voluntary agreement as a basis for model exclusion or as one of the alternatives considered, and the public thus has not had an opportunity to comment on any such policy proposal," Richard Frank of the Brookings Institution, Kristi Martin of Highway 136 Consulting and Rachel Sachs of Washington University, St. Louis, said... Global Sub. Full

 

Medicare's $100 Billion Decision: Biologics, Biosimilars and Prescription Drug Price Negotiations

(3/31, Sue Peschin, Medical Economics) ...First, the FDA can quickly review pending biosimilar applications to help bring them to the market faster. Second, in future negotiations, CMS can promote competition by accounting for these upcoming biosimilar launches when making its selections. And third, Congress could pass reforms such as the Biosimilars Access and Affordability Act, which would temporarily prevent Medicare officials from selecting brand-name biologics that will soon face biosimilar competitors for the price negotiation program... Full

 

CPA Urges CMS, HHS to Boost Domestic Production of Generic Pharmaceuticals

(3/31, The Coalition for a Prosperous America) ..."America's healthcare system cannot remain dependent on fragile and subsidized foreign supply chains for generic pharmaceuticals and other critical countermeasures that are fundamental to patient care," said Jon Toomey, president of CPA. "CMS has a timely opportunity to use Medicare's purchasing power to rebuild domestic manufacturing capacity, strengthen supply chain resilience, ensure higher standards of quality and safety for patients, and bolster our national security against such critical industries propped up and heavily subsidized by the Chinese state military apparatus."... Full

 

America's Weight-Loss Drug Boom Has a Dangerous Blind Spot

(3/31, Jimmie Wilson, The Washington Post) ...Compounding pharmacies exist to make custom formulations for patients who can't take branded medications for medical reasons, such as a patient who is allergic to a dye in a medicine. These pharmacies were not intended, nor are they equipped, to safely mass-produce drugs such as tirzepatide. Many of these pharmacies rely on active pharmaceutical ingredients (API) sourced from unregulated overseas suppliers. In my case, we later learned that the pharmacy obtained its API from China, where many of these ingredients are produced in facilities not registered with or inspected by the FDA... Sub. Req'd

 

Consumer Group Urges HHS To Override Patents As Semaglutide Generics Face U.S. Delay

(3/31, Maaisha Osman, Inside Health Policy) ...The leading consumer advocacy group Public Citizen is urging the federal government to use its "government use" authority to break patent barriers on blockbuster GLP-1 drugs, arguing that allowing generic production of semaglutide and tirzepatide could sharply reduce prices and expand access for millions of patients facing obesity and diabetes... Sub. Req'd

 

Pharma Confronts 'Moving Bar' for Vaccines, Drugs Under RFK Jr.

(4/1, Nyah Phengsitthy, Bloomberg Law) ..."When one product class appears to be getting a faster path while another is encountering added evidentiary demands or policy turbulence, companies start rethinking capital allocation, development timing, and market priorities," said David Dodd, CEO of GeoVax Labs Inc., a biotech developing vaccines against infectious diseases and cancers. "Biopharma can operate under a high bar, but it struggles under a moving bar."... Sub. Req'd

 

Virginia Wants to Improve Medicine Affordability. This Act Will Not Do That. | Guest Column

(3/31, John Newby, Richmond Times-Dispatch) ...[T]he path to lower costs has been littered with state-run prescription drug regulatory schemes that have not yielded patient savings at the pharmacy counter. The Affordable Medicine Act puts Virginia at risk of joining those failed state efforts. Instead, more transparency in drug distribution and pricing is the path toward greater patient access to affordable drugs. We urge Governor Spanberger to put Virginia patients, jobs and innovation first and veto these bills... Full

 

 

Celltrion Launches Omlyclo in Brazil, Eyes Latin America Growth

(3/31, Jeon Ji-woo, The Korea Herald) ...The company said it has already secured initial supply channels by winning a state government tender in Santa Catarina, enabling early distribution in the public health care system. Additional tender wins are expected as the rollout expands... Full

 

Celltrion Streamlines Keytruda Biosimilar Trial Amid FDA Shift

(4/1, Dean Rudge, Generics Bulletin) ...While Celltrion did not explicitly link the CT-P51 amendment to specific regulatory developments, the timing aligns closely with newly updated guidance from the US Food and Drug Administration aimed at simplifying biosimilar development requirements... Global Sub. Full

 

South Korea's Biosimilar Boom Enters High-Stakes ‘Third Wave'

(4/1, Ayesha Siddiqui, Biospectrum Asia) ...Apart from a strong domestic market, South Korean companies have also built a growing presence in global biosimilars. According to GlobalData's Pharmaceutical Intelligence Center, 24 biosimilars developed by Korean firms are approved across international markets, including 11 monoclonal antibodies. Another five products are in pre-registration across 10 therapy areas, indicating continued pipeline expansion. Around 15 companies are active in development... Full

 

What's Next? Five Things To Look Out For In April

(4/1, Dean Rudge, Generics Bulletin) ...In April, the US Food and Drug Administration's Generic Drugs Forum will take place at the agency's White Oak Campus in Silver Spring, Maryland, with the aim of improving the quality and efficiency of generic drug submissions...Over two days, participants will engage with topics such as controlled correspondence, pre-ANDA and ANDA submissions, regulatory meetings, quality and manufacturing standards, and drug master files. Case studies and advanced regulatory topics will also be covered to provide practical, application-focused insights... Global Sub. Full

 

Op/Ed: Why Financial Discipline Is the Driver of U.S. Generic Drug Affordability

(3/31, Amber Hussain Siddique, Pharmaceutical Commerce) ...The next phase of generic drug affordability will not be driven solely by policy reform. It will be driven by how effectively companies manage their internal economics, through disciplined inventory management, optimized logistics, and efficient capital deployment... Full

 

 

Pharma Goes on $25.5B, Eight-Day Acquisition Spree

(4/1, Kyle LaHucik, Endpoints News) ...It's no surprise. Large drugmakers are filling their late-stage pipelines to fend off patent cliffs, padding out earlier R&D engines to extend their dominance in certain fields, and doubling down on emerging therapeutic classes. Across March, biopharmas lined up 10 acquisitions worth up to $31.5 billion, according to an Endpoints News tally. Eight of those included contingent value rights or milestone payments reliant on R&D or regulatory achievements, a dealmaking structure that has become more common in recent years... Sub. Req’d

 

Big Drug Companies Hunting for Deals Are Lowering Their Sights

(3/31, Peter Loftus and Xavier Martinez, The Wall Street Journal) ...The deals are part of a run of small and midsize pharma acquisitions -- a range that has become a sweet spot for companies seeking to bolster the work of their own labs or lineups. "If you do a lot of these little bolt-on deals, you can kind of craft your own portfolio that could totally complement something that you have going on internally," said Karen Anderson, director of healthcare equity research at Morningstar... Sub. Req’d

 

Biogen, Eyeing Swift Commercial Tailwind, Ponies up $5.6B for Apellis and its 2 Approved Meds

(3/31, Fraiser Kansteiner, Fierce Pharma) ...For Biogen, the deal grants access to the approved Apellis meds Syfovre for the eye condition geographic atrophy (GA) and Empaveli, approved by the FDA last year in the rare kidney diseases complement 3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN)...Under the arrangement, which is expected to close in the second quarter, Apellis investors will also receive a contingent value right (CVR) for each company share held. The CVR will be worth up to $4 per share, depending on certain sales thresholds for Apellis' products being met, Biogen said... Full

 

CapVest Hints At 'Ambitious Plans' For Stada As It Completes Takeover

(3/31, Dave Wallace, Generics Bulletin) ...CapVest said the transaction would "allow the CapVest and Stada teams to jointly progress their ambitious plans to accelerate the growth of the company globally and deploying capital towards pursuing organic growth and new strategic acquisitions."... Global Sub. Full

 

API Supplier BASF Raises Prices Up to 20% in Response to Rising Energy, Raw Material Costs

(3/31, Zoey Becker, Fierce Pharma) ...Global chemical production company BASF Pharma Solutions is increasing its prices by up to 20% for its excipients and a select array of its APIs, the company announced in a Monday press release. The price change will take effect immediately or as BASF's existing contracts allow... Full

 

Novo Nordisk Rolls Out Wegovy Subscription

(3/31, Elizabeth S. Eaton, FirstWord PHARMA) ..."The new Wegovy subscription programme removes barriers, providing people who enroll a simple, affordable, and consistent way to start and stay on genuine, FDA-approved treatment," said Ed Cinca, Novo's senior vice president, marketing and patient solutions. "By providing predictable monthly pricing, multi-month options, and access through trusted telehealth providers, this programme aims to support a more manageable way for people to stay on treatment and focus on achieving meaningful, sustainable weight loss outcomes.".. Full

 

Novo Nordisk Cuts Ozempic, Wegovy Prices in India Again to Fight Cheaper Generics

(3/31, Rishika Sadam, Reuters) ... Ozempic's and Wegovy's lowest doses of 0.25 mg in India will now be priced at 1,415 rupees ($15.04) for a weekly shot from 2,200 rupees and 2,712 rupees earlier, respectively, Novo Nordisk India said in a statement on Tuesday. The average price reduction across doses is 23.8% for Ozempic and 27% for Wegovy, it said. "We've heard from patients and doctors, and we're acting on that feedback," said Vikrant Shrotriya, managing director at Novo Nordisk India, adding that the drugs also offer cardiovascular benefits... Sub. Req’d

 

FDA Flags Serious Liver Injury Cases, 8 Deaths with ‘Reasonable' Link to Amgen's Tavneos

(3/31, Zoey Becker, Fierce Pharma) ...From the drug's approval in 2021 through October 2024, 76 cases of drug-induced liver injury with "reasonable evidence" of a causal association to Tavneos were reported to the FDA Adverse Event Reporting System (FAERS), according to a Tuesday safety communication... Full

 

 

Boehringer Issues Warning To Innovation-Unfriendly Europe

(3/31, Kevin Grogan, Pink Sheet) ...[Boehringer Ingelheim chairman Shashank Deshpande] told the Pink Sheet's sister publication, Scrip, at the German group's annual press conference that "we're clearly seeing a decline in European competitiveness whichever metric we use, whether it is clinical trials, new drugs approved or biotech deals." He added that "we used to be, especially in this country, the pharmacy of the world and as we look at declining output and increasing regulation, we are also worried that Europe is falling further behind."... Global Sub. Full

 

Europe Must Pay More for Medicines, Says Bayer

(4/1, Florian Muller and Aanu Adeoye, Financial Times) ..."The American government has made it clear it does not see why the US should finance global R&D alone," he said, adding that Europe would "have to reorient" towards higher price levels over time...The comments come as the industrial conglomerate pushes a turnaround of its pharma business following a wave of patent expiries and pivots towards the US as its main source of growth. The company expects the US to become its largest market, having increased the size of its sales and marketing operations in the country... Sub. Req'd

 

Biosimilar Streamlining Takes A Further Step Forward In Europe

(3/31, Dave Wallace, Generics Bulletin) ...The EMA said the newly-adopted reflection paper on a tailored clinical approach in biosimilar development showed how it had "re-evaluated" the importance of dedicated comparative clinical efficacy and safety data, given advances in analytical science and its now "extensive regulatory experience"... Global Sub. Full

 

Pharma Industry Raises Concerns as EU Consults on Plan to Ban PFAS

(3/31, Emily Hayes, Regulatory Focus) ...Stakeholders are being encouraged to weigh in on the European Chemicals Agency (ECHA) 60-day public consultation period related to a planned ban on per-and-polyfluoroalkyl (PFAS) substances, also known as forever chemicals... Full

 

Head of NHS England 'Really Worried' About Medicine Supplies

(3/31, Jamie Grierson and Denis Campbell, The Guardian) ...The NHS England chief executive, Jim Mackey, was asked during a phone-in on LBC Radio on Tuesday what contingency planning was in place because "the UK imports 75% of its medicine". He said: "We are really worried about this. We've already had a couple of supply shocks in the last 12 to 18 months of key supplies." He said a team was in place to "focus on where the risks might be through the supply chains"... Full

 

Iran Claims US-Israel Strikes Targeted Major Pharmaceutical Company

(3/31, AFP) ...The pharmaceutical company is named as Tofigh Daru Research & Engineering Company, which is owned by the Social Security Investment Company, a state-run holding firm... Full

 

Israel Strikes Tehran Pharmaceutical Plant, Claiming Military Link

(3/31, Parin Behrooz and Ephrat Livni, The New York Times) ...The Israeli military said in a statement late in the day that it had struck the Tofigh Daru factory, claiming the facility was secretly supplying a potentially deadly drug to the Organization of Defensive Innovation and Research of Iran, which Israel says is responsible for developing chemical weapons... Sub. Req’d

 

Why India Is Considering The Essential Commodities Act For Pharma Amid US-Iran War

(4/1, Vibha Ravi, Pink Sheet) ...The war between the US-Israel coalition and Iran might prompt the Indian government to invoke the Essential Commodities Act to maintain equitable distribution and availability of pharmaceutical raw materials to minimize the possibility of finished drug supply being disrupted. Already, prices of solvents, intermediates, active pharmaceutical ingredients (APIs), excipients and packing materials have spiked for pharma firms manufacturing in India... Global Sub. Full

 

India's Biologics Dream Hits Chinese Wall

(4/1, Rupali Mukherjee, The Times of India) ...Indian firms hoping to ride the global biologics boom are finding the path far tougher than expected, as China tightens its grip further on biotech supply chains. Recent data suggests Chinese companies have bagged more than half of several recent project deals from US biotech companies, underscoring the challenge for Indian players trying to break into complex biologics. Unlike generics, where India leveraged cost efficiency and scale to capture global markets, biologics demand deep R&D capabilities, sophisticated manufacturing infrastructure and specialised talent, raising both entry barriers and financial risks, analysts say... Full

 

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