Thursday, March 27, 2025

Alvotech Reports Record Results for 2024 and Provides Business Update

(3/26, Alvotech) ..."Our 2024 results demonstrate Alvotech's best-in-class and end-to-end manufacturing and R&D capabilities, made possible by the substantial investments in infrastructure and development over the past decade," said Robert Wessman, Chairman and CEO of Alvotech. "We reached record revenue from both products sales and development milestones, as well as positive EBITDA for the first time in our history. More importantly, we accomplished these results while completing a record year in development, filing three submissions in major global markets that pave the way for near term growth. Our earlier stage pipeline offers further operating leverage."... Full

Alvotech And Advanz Make First Omalizumab Filing

(3/26, Dave Wallace, Generics Bulletin) ...With Alvotech citing global sales of Xolair that came to around $4.4bn in 2024, omalizumab is a significant target for the biosimilars developer. And under the deal struck between Alvotech and Advanz in early 2023, Advanz will have "exclusive rights to register and commercialize" the biosimilar in the European Economic Area, the UK, Switzerland, Canada, Australia, and New Zealand, with Alvotech taking care of development and commercial supply... Global Sub. Full

Fresenius Says FDA Approved Biologics License Application for Bone-Disease Drugs

(3/26, Pierre Bertrand, Dow Jones) ...The German healthcare company said Wednesday that Fresenius Kabi reached a global settlement with Amgen concerning denosumab biosimilars. The settlement allows for the launch of biosimilars in the U.S. from mid 2025 and in the second half of the year in Europe, subject to regulatory approvals, Fresenius said... Full

Celltrion's Remdantry™, Previously Known as Inflectra®, Will Be Available in Canada as of April 1, 2025

(3/27, Celltrion, Inc.) ...Remdantry™ (previously known as Inflectra®), developed and manufactured by Celltrion, is the first monoclonal antibody biosimilar infliximab in Canada and will be commercially available across Canada as of April 1, 2025. Celltrion offers a full-service patient support program offering a wide range of services from financial assistance to patient education in Canada... Full

Novartis Flags Entresto Risk as MSN Seeks to Delist Patent

(3/26, Christopher Yasiejko, Bloomberg Law) ...The Federal Circuit's mandate, which will formalize the decision and make its injunction enforceable, is expected to be issued by April 1, according to Novartis' letter seeking clarity. Judge Richard G. Andrews said Wednesday in an oral order that the Delaware district court doesn't have jurisdiction until the Federal Circuit's mandate is issued... Sub. Req’d

AEON Eyeing FDA Meeting On Botox Biosimilar By The End Of 2025

(3/26, Dean Rudge, Generics Bulletin) ...AEON Biopharma has kicked off the primary analytical studies that are required for its ABP-450 proposed biosimilar to Botox (onabotulinumtoxinA) to fulfill the standard regulatory requirements for a comparative analytical assessment, under plans to file eventually the biosimilar via the US Food and Drug Administration's 351(k) regulatory pathway... Global Sub. Full

India's Aspen Biopharma Labs Hit with FDA Warning Letter Citing Infrastructure, Contamination and Records Problems

(3/26, Joseph Keenan, Fierce Pharma) ...With its active pharmaceutical ingredient (API) facility "in a state of disrepair," manufacturer Aspen Biopharma Labs' operations have ground to a halt in the U.S., according to a recent FDA reprimand. Aspen Biopharma has been hit with an FDA warning letter outlining multiple issues at the company's production facility in the Indian city of Hyderabad, including poor building design that could lead to drug contamination... Full

Roche's Ocrevus, Novartis' Kesimpta Set to Lead CNS Market to Strongest Growth in Over a Decade: Report

(3/26, Andrea Park, Fierce Pharma) ...The market is on the rise in the wake of successful developments in MS treatments, specifically the use of anti-CD20 monoclonal antibodies to treat relapsing MS, which have "solidified neuroimmunology as a commercially viable and high-growth space," according to the report. GlobalData spotlighted Roche's Ocrevus and Novartis' Kesimpta as leaders in the space; Ocrevus, in particular, is expected to reel in more than $8 billion in sales this year, representing around 10% of the total market... Full

Tariff Threat Sends Health Players Scrambling for Carve-Outs

(3/27, Adriel Bettelheim and Tina Reed, Axios) ...This week, Trump also said he would be announcing tariffs specifically targeting pharmaceuticals, in addition to autos. On Wednesday, he announced 25% duties on imported cars, effective on April 2, saying they were imposed to nudge the manufacturers to build plants and produce vehicles domestically... Full

Pharmaceutical Tariffs: Potential Impacts And The Need For Vulnerability Assessments

(3/26, Thomas Roades Stephen Colvill Mark B. McClellan, Health Affairs) ...However, applying tariffs broadly to pharmaceuticals or their ingredients is not the best policy option to achieve these goals. Tariffs are likely to create pressure for higher prices and cause unintended consequences, such as increased drug shortages of generic medicines with fragile supply chains that will affect costs and health outcomes for health care systems, insurers, and patients... Full

Klobuchar, Grassley Introduce Bipartisan Bills to Reduce Drug Prices by Promoting Competition and Taking On Big Pharma

(3/26, United States Senator Amy Klobuchar) ..."Prescription drug prices are too high—driven up by excessive consolidation in the pharmaceutical industry and abusive business tactics that keep more affordable medications off the market and out of reach for far too many Americans," said Klobuchar. "Our bipartisan legislation would deter anticompetitive deals and sham petitions that prevent generic drugs from entering the market and prevent Americans from accessing affordable, life-saving drugs."... Full

Carter: House Leadership Commits To Put PBM Reforms In Reconciliation Bill

(3/26, Gabrielle Wanneh, Inside Health Policy) ...House Energy & Commerce Committee Chair Buddy Carter (R-GA) said Wednesday (March 26) he has a commitment from House Speaker Mike Johnson (R-LA) and other House leaders that pharmacy benefit manager (PBM) reforms, which were axed from a continuing resolution package passed in December, will be included in the upcoming reconciliation deal... Sub. Req’d

Optum Rx Remodels Payment Model To Favor Generics – A Peace Offering For FTC?

(3/26, Urte Fultinaviciute, Generics Bulletin) ...With this remodeling, which came into effect on March 20, and will be fully implemented by January 2028, Optum Rx is "addressing a legacy, industry-wide model that was originally designed to help promote the use of affordable generics." The firm said that despite effective generic drug adoption becoming "quite strong," high-cost branded drugs are increasingly entering the market, which raises costs for pharmacies. By addressing the cost imbalance, the change will provide pharmacies with better financial means to stock more medicines, which, in return, will alleviate drug shortages in the US... Global Sub. Full

Think Tank Suggests CMS, USTR Could Enforce Most Favored Nation, Other Drug Pricing Policies

(3/26, Cathy Kelly, Pink Sheet) ...Variations of the Most Favored Nation and International Pricing Index models developed in the first Trump Administration could be resurrected to address 'global freeloading' of US R&D efforts, the America First Policy Institute suggested. The issue brief also proposed applying tariffs and other trade levers to raise the prices foreign governments pay for drugs to increase their contribution to R&D efforts. The Trump Administration is expected to return to policies related to international reference pricing, but biopharma wants to ensure they focus on raising prices abroad and not just lowering them in the US... Global Sub. Full

D.C. Joins $39.1M Generic Drug Price-Fixing Settlement, AG Schwalb Urges Residents to Check Eligibility for Payouts

(3/26, Stacy M. Brown, The Washington Informer) ...The settlement represents a portion of a broader legal effort that began in 2016 when attorneys general filed the first of three sweeping antitrust complaints. The initial lawsuit included Heritage and 17 other companies, while subsequent complaints have expanded to include Teva Pharmaceuticals and Sandoz, among others. The complaints cover at least 80 topical generic drugs and name over 50 corporate and individual defendants... Full

Biosimilars Forum Executive Director Juliana Reed to Speak at Evolution of Biosimilars Development Workshop

(3/26, Biosimilars Forum) ...Juliana Reed, executive director of the Biosimilars Forum, will speak at the DIA Evolution of Biosimilar Development Workshop on May 21, 2025. Reed will discuss the current state of the biosimilars industry, highlighting the need for Americans to have increased access to lower-cost biosimilars... Full

Targeting FDA User Fees Would Leave Agency Gutted, Experts Say

(3/27, Lia DeGroot, Roll Call) ...[Mark McClellan, the director of the Duke-Margolis Institute for Health Policy] said if user fees were eliminated, there would need to be additional appropriated funds for the FDA to fully operate, which he said would be challenging for Congress to agree to. He underscored that losing that funding would result in slower approval times and less clear approval decisions that would ultimately result in poor outcomes for health... Full

Can New US FDA Commissioner Makary Calm Agency During Turbulent Times?

(3/26, Sarah Karlin-Smith, Pink Sheet) ...Stakeholders are closely watching newly confirmed US FDA Commissioner Martin Makary to see if he sides with the Trump Administration's disruption of federal agencies or tries to restore more typical FDA operations. Many FDA stakeholder groups hope Makary will uphold the agency's rigorous scientific standards. However, Makary may have trouble standing up for strong science on some topics, given his bosses in the administration... Global Sub. Full

Novo Nordisk Accord With Minnesota On Insulin Prices Approved

(3/26, Jazper Lu and David Voreacos, Bloomberg Law) ...A federal judge approved a settlement between Novo Nordisk A/S and Minnesota to cap the out-of-pocket cost of insulin at $35 a month for state residents, following similar accords with other drugmakers... Sub. Req’d

House Revisits Prescription Drugs But Drops Healey Tax Plans

(3/26, Sam Drysdale, The Boston Globe) ...The House Democrats redrafting Governor Maura Healey's budget won't adopt her plan to add new taxes on prescription drugs, House Speaker Ron Mariano said Wednesday, appearing to take off the table more than $200 million in proposed levies. Mariano told pharmaceutical leaders at MassBio's "State of Possible" conference that the House would drop the idea Healey included in her $62 billion annual budget bill in January...Mariano on Wednesday also announced his chamber would revisit some House-backed initiatives that didn't make it into the pharmaceutical law lawmakers hammered out late last year... Sub. Req’d

Europe Rapidly Falling Behind China in Pharma, Astra Chief Warns

(3/26, Bloomberg) ...Europe is fast losing its edge to China in pharmaceutical innovation, AstraZeneca Plc Chief Executive Officer Pascal Soriot warned. "The two large innovators in our industry today are the US and China," the executive said on the sidelines of the Boao Forum for Asia in Hainan province. "China is, I think over the next five to 10 years, going to emerge as really a driving force for innovation in our sector."... Sub. Req’d

EU Health Data Space Strikes a Chord in EU Harmonisation Plans

(3/26, Akosua Mireku, Pharmaceutical Technoloy) ...The European Commission (EC) first proposed the EHDS regulation in March 2024, followed quickly by an approval from European parliament in April. The regulation was adopted on March 5, this year, and will be enforced by individual member states today, on March 26. The new regulation should "generate €11 billion in savings over the next decade by enhancing data accessibility" and "healthcare service efficiency across EU member states", says the European Commission on its website... Full

German Parties in Coalition Talks Want Country to be EU's Biggest Pharma Player

(3/26, Magdalena Kensy, Euractiv) ...Germany's Christian Democrats and Social Democrats, currently in talks to form the next coalition government, want the country to be a top European pharmaceutical player, according to the final text of the health and care working group seen by Euractiv. Leaders of both parties are currently negotiating a comprehensive coalition agreement. While there are still some outstanding issues, the parties reached an agreement regarding the health file... Sub. Req’d

American Pharmaceutical Boss Does Not Support Tariffs On Australian Medicines

(3/25, Neve Brissenden and Sarah Ferguson, ABC) ...The head of one of America's largest pharmaceutical companies says he does not support tariffs on Australian pharmaceuticals as US President Donald Trump considers more trade restrictions...Pharmaceutical companies say the system minimises innovation and doesn't allow Australians to access the medications they desperately need quick enough. "We think it's important to fairly value breakthroughs that have a real consequence on the health of Australians … and we should be rewarded for that," Mr Ricks said. "When we don't deliver medicines that do that, we shouldn't be rewarded."... Full

Exclusive: Critical Medicines for Cancer, Diabetes Set to Get Expensive as Govt Clears Price Hike, Say Sources

(3/26, Ghetan Bhutani, Business Today) ...All India Organisation of Chemists and Druggists (AIOCD) General Secretary Rajiv Singhal told Business Today that it will help the pharmaceutical industry to raise prices as the cost of raw materials and other expenses is increasing day by day, hence providing some relief to the industry. He further said: "As far as the trade is concerned, it will take another two to three months to see the new prices of medicines in the market, as there are approximately 90 days of saleable medicines in the market at any given time."... Full

NPPA to Allow 1.74% Hike in MRP of Scheduled Drugs in Line with WPI Rise

(3/26, Sanket Koul, Business Standard) ...The National Pharmaceutical Pricing Authority (NPPA) on Wednesday announced that manufacturers may increase prices of scheduled drugs included in the National List of Essential Medicines (NLEM) by 1.74 per cent, on the basis of changes in the wholesale price index (WPI)... Full

China to Spur Innovation Through New Reimbursement List

(3/26, Wang Fangqing, The Pharma Letter) ...The Chinese government is contemplating a new drug reimbursement category called category C to make commercial insurance companies a major payer. If the new category is introduced, it is expected to significantly accelerate China's innovation, said speakers at the BIOCHINA event held in Suzhou. Unlike drugs covered by category A and B, which are procured and reimbursed by the Chinese government, category C drugs will be co-paid by insurance companies... Sub. Req’d

Concerta Shortage Drives Surge in ADHD Drug Use Among Non-Patients in Korea

(3/27, Yeom Hyun-a, ChosunBiz) ...Concerta has recently become hard to find as supply cannot keep up with demand. Whan In Pharm reported the supply shortage of Concerta to the Ministry of Food and Drug Safety three times: in April and July last year and in February of this year. The industry expects supply to normalize by the end of May as Janssen has been increasing production at its U.S. factory. Due to the scarcity of Concerta, alternative medications with the same active ingredient are also gaining attention... Full

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