Wednesday, February 19, 2025

FDA Accepts Alvotech/Teva's Application for Eylea Biosimilar

(2/18, Denise Myshko, Managed Healthcare Executive) ...So far, five biosimilars that reference Eylea 2 mg have been approved by the FDA. Alvotech/Teva expect to regulatory approval for its biosimilar to be completed in the fourth quarter of 2025...Alvotech and Teva Pharmaceuticals have partnered for the development of AVT06, a biosimilar candidate Eylea 2 mg; Alvotech is currently also developing AVT29, a biosimilar candidate for Eylea HD 8 mg... Full

Aflibercept Biosimilar AVT06 Up for Review for Inherited Retinal Diseases

(2/18, Victoria Johnson, HCP Live) ..."We are delighted to share this latest biosimilar milestone with Alvotech for those living with retinal diseases," Thomas Rainey, Senior Vice President, U.S. Biosimilars at Teva, added. "This acceptance continues to build on our shared commitment to improving patient outcomes by offering cost saving and accessible options."... Full

Vanda Falls Again As Teva, FDA Win Judgment In ‘Unlawful' Tasimelteon Approval Case

(2/18, Dean Rudge, Generics Bulletin) ...A US district court in Washington D.C. has ruled in favor of Teva in Vanda Pharmaceuticals' bid for summary judgment arguing that the US Food and Drug Administration's approval of Teva's generic version of the originator's Hetlioz (tasimelteon) was unlawful, marking another defeat for serial litigator Vanda... Global Sub. Full

Formycon Faces Choppy Waters Amid US Biosimilar Pricing Storm

(2/18, Dave Wallace, Generics Bulletin) ...Unleashing a trio of major announcements, Formycon has indicated a gloomy outlook for US Stelara biosimilar pricing; revealed plans to pause commercialization of its Sandoz-partnered US Cimerli rival to Lucentis amid discounting from rivals; and set out ambitious plans to win FDA approval for its proposed Keytruda biosimilar without any Phase III data... Global Sub. Full

Polpharma Secures Government Funding For Complex Inhalable And Injectable Generics

(2/18, Adam Zamecnik, Generics Bulletin) ...Specifically, the Polish generic drug maker received a grant for the development of inhalable complex generic drugs for the treatment of respiratory diseases such as chronic obstructive pulmonary disease and asthma. Additionally, the funding will also go towards the advancement of an injectable generic type 2 diabetes treatment. While the company did not disclose further details of what particular compounds these two projects are researching, its announcement stated that the type 2 diabetes drug belongs to the "polypeptide group"... Global Sub. Full

Hikma Takes Amarin's 'Skinny Label' Fight to the Supreme Court

(2/18, Alexis Kramer, Endpoints News) ...Hikma Pharmaceuticals is asking the US Supreme Court to review a generic drug labeling ruling that it says will "effectively vitiate" a common practice that helps bring more low-cost medications to market. The petition, filed on Friday and obtained by Endpoints News, seeks review of a Federal Circuit decision that revived Amarin's patent lawsuit against Hikma... Full

Sandoz to Pay $275 Million to Settle Drug Price-Fixing Case

(2/18, Mike Scarcella, Reuters) ...Swiss generic drug manufacturer Sandoz has agreed to pay $275 million to resolve claims by U.S. consumers and others who accused the company of conspiring with industry rivals to illegally fix prices...The antitrust case includes several drug makers that were not part of Friday's settlement, including Pfizer, Teva and Lupin. The companies did not immediately respond to requests for comment and have denied wrongdoing... Full

Aurobindo Pharma Shares Decline Following US FDA Inspection

(2/19, Heena Ojha, NDTV Profit) ...The inspection concluded with five observations, which Aurobindo Pharma has committed to addressing within the stipulated time frame. Shares of Aurobindo Pharma Ltd. fell by over 9% on Tuesday, following announcement of the completion of a US FDA pre-approval inspection at Eugia Steriles Pvt., a 100% step-down subsidiary located in Parawada Mandal, Andhra Pradesh... Full

Trump Says He Will Introduce 25% Tariffs On Autos, Pharmaceuticals and Chips

(2/18, Andrea Shalal and Nandita Bose, Reuters) ...Trump told reporters at his Mar-a-Lago estate in Florida on Tuesday that sectoral tariffs on pharmaceuticals and semiconductor chips would also start at "25% or higher", rising substantially over the course of a year. He did not provide a date for announcing those duties and said he wanted to provide some time for drug and chip makers to set up U.S. factories so that they can avoid tariffs... Full

Pharma Leaders to Meet Trump in Push to Tweak Drug Policies

(2/18, Damian Garde, Madison Muller and Josh Wingrove, Bloomberg) ...The summit comes two days after PhRMA rented out a concert venue for a lavish meeting in Washington, D.C., where executives spoke effusively about the industry's future under Trump while echoing the president's concerns about rising competition from China...Pfizer Inc. Chief Executive Officer Albert Bourla said the new administration brings "boldness" to the White House, in contrast to the "extreme left" that steered the Biden administration's approach to the industry. The CEOs of GSK Plc, Novartis AG and Merck & Co. were also in attendance at the event in Washington... Full

Pharma Leaders to Meet Trump in Push to Tweak Drug Policies

(2/18, Damian Garde, Madison Muller and Josh Wingrove, Bloomberg ) ...Prem Shah, the executive Vice President and Group President of CVS Health joined Bloomberg Open Interest to talk about where he sees US healthcare under Trump's second term... Full

Inside Trump's Million-Dollar Dinners With Healthcare Executives

(2/18, Josh Dawsey, Anna Wilde Mathews, The Wall Street Journal) ...Since the dinners, Trump has publicly embraced arguments he heard from the executives, even if the ideas conflicted, according to people familiar with the conversations. In between small talk at a November dinner, Pfizer Chief Executive Albert Bourla and the other pharmaceutical executives told Trump that insurance companies and middlemen known as pharmacy-benefit managers were to blame for high drug prices. The next month, Trump repeated their position at a news conference. "We're going to knock out the middleman," Trump said. "They don't do anything."... Full

Pfizer CEO Albert Bourla: Focusing On Opportunities Outside of Vaccines with RFK Jr.

(2/18, CNBC) ...Albert Bourla, Pfizer CEO, joins CNBC's Angelica Peebles and ‘Closing Bell Overtime' to talk the impact of tariffs, Pfizer's drug pipeline, vaccines and more... Full

Pfizer's Manufacturing Arm at Risk from Trump Tariffs in Europe, Bourla Says

(2/19, Anna Brown, Endpoints News) ...Pfizer CEO Albert Bourla said its manufacturing business could be vulnerable to President Donald Trump's tariffs in Europe as the pharma giant has "significant" presence in the region. Its contract manufacturing arm Pfizer CentreOne has around 12 facilities across the continent... Full

CVS Group Pres. Explains PBMs' Vital Role in Negotiating Drug Costs

(2/18, Yahoo! Finance) ...As pharmaceutical companies prepare to meet with the Trump administration to negotiate drug prices, CVS Health (CVS) executive vice president and group President Prem Shah sits down with Yahoo Finance senior health reporter Anjalee Khemlani and Julie Hyman on today's episode of Market Domination. Shah speaks on the role pharmacy benefit managers (PBMs) have in negotiating drug prices... Full

ADHD Patients, Doctors Scared of Losing Medication Under RFK Jr

(2/18, Sara Libby, San Francisco Chronicle) ...As a presidential candidate, Kennedy said he wanted to create "wellness farms" where people could detox from illegal substances — but also legally prescribed psychiatric drugs, including Adderall. "He is against the use of medication for ADHD in spite of research demonstrating that these medications are safe and can prevent deaths among people who take them," the Autism Self Advocacy Network wrote in a statement condemning Kennedy's confirmation. "He has falsely linked antidepressants, which for many people are life-saving medication, to mass shootings. None of these beliefs are based on evidence, and all of them would make terrible public health policy."... Sub. Req’d

AAM Annual Meeting – Members Only Regulatory Session

(2/18, Bob Pollock, Lachman Consultants) ...This session is always a highlight, and one of my favorite sessions, offering insight into key regulatory and scientific issues that the AAM is currently tackling as well as those that it plans to address in the future. The session also provides a forum for AAM members to raise emerging industry concerns and discuss how AAM can work with its members to address these issues... Full

US FDA Staff Cuts: Biopharma Industry Braces For Impact, But First Wants Clarity On Losses

(2/19, Sue Sutter, Pink Sheet) ...The biopharmaceutical industry likely will feel the impact of the Trump Administration's weekend purge of hundreds of US Food and Drug Administration probationary employees in many ways over the coming weeks and months...The potential effects could be wide-ranging, including delayed inspections, slowed application reviews and hindered advances of the FDA's artificial intelligence policy. The layoffs also could spur the departure of center and office directors and other agency veterans in the near-term and hamstring the agency's future recruiting efforts... Global Sub. Full

Generic Drugmakers Win a Long-Running Battle with California Over a Law to Ban Pay-to-Delay Deals

(2/18, Ed Silverman, STAT+) ...California officials were dealt a setback by a federal judge who ruled that a controversial law banning so-called pay-to-delay deals between pharmaceutical companies is, in part, unconstitutional and so cannot be enforced against agreements that had no link to the state. In his ruling, U.S. District Court Judge Troy Nunley determined that the state law, which was enacted in 2019, violated the Dormant Commerce Clause of the U.S. Constitution because it would extend to pay-to-delay agreements that happened outside of California and, therefore, attempted to regulate interstate commerce... Sub. Req’d

‘India Supplies 47% Generic Medicines to US…': IPA Responds to Trump's 25% Tariff Threat

(2/19, Sushmita Panda, Financial Express) ..."The Indian pharmaceutical industry plays a vital role in ensuring access to affordable, quality-assured medicines in the US, supplying nearly 47% of the generic medicines for the American patients and contributing significantly to the country's healthcare savings. The proposal regarding reciprocal tariffs is currently under talks and is being examined. This matter will be discussed through bilateral engagements between the two countries, and further steps will be determined accordingly," Sudarshan Jain, Secretary General, Indian Pharmaceutical Alliance (IPA) told Financial Express.com... Full

Indian Drugmakers with Big US Exposure As Trump Plans Pharmaceutical Import Tariffs

(2/19, Rishika Sadam, Reuters) ...India's drugmakers export generic drugs to the U.S., offering a cost-effective alternate to expensive innovative drugs. Nearly half of all generic prescriptions filled in the U.S. in 2022 were supplied by Indian drugmakers and generated $408 billion in savings for the U.S. healthcare system for the year, according to research firm IQVIA. Following are India's major drugmakers relying heavily on the U.S. market... Full

Agreement Signed Between Malta and Italy to Strengthen Pharmaceutical Sector

(2/18, The Independent) ...A government statement on Tuesday said that the agreement aims to enhance cooperation between Malta and Italy to achieve shared goals in European pharmaceutical policy and beyond. It said that this agreement not only reaffirms the strong bond between the two nations but also underscores Malta's commitment to collaboration within the EU and, most importantly, to improving healthcare for its patients... Full

Michel Robidoux of Sandoz Canada Elected Chair of Canadian Generic Pharmaceutical Association

(2/18, The Canadian Generic Pharmaceutical Association) ...Ray Shelley, President of Apotex Canada, has been unanimously elected as Vice Chair of CGPA. Mr. Robidoux said that the industry's focus remains working with government and all stakeholders in the supply chain to ensure a stable, predictable market for the sector, and the continued supply and introduction of cost-saving generic prescription medicines for Canadians... Full

France Gives Fresh Impetus To Economic Evaluations In Five Year Strategic Plan

(2/18, Francesca Bruce, Pink Sheet) ...France's health technology appraisal body, HAS, is putting more emphasis on the importance of economic evaluations in light of the rising costs of health technologies, including medicines and medical devices, and increasing budgetary pressures... Global Sub. Full

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