Wednesday, December 11, 2024

October Surprise: How Amgen's Aflibercept Launch Shook Up US Biosimilars In 2024

(12/11, Dave Wallace, Generics Bulletin) ...All of this pushed back expectations of biosimilar competition significantly, with a growing consensus that Eylea rivals may not reach the US market until 2027. However, when it came to Amgen and its Pavblu version, the firm pulled off something of a coup...It remains to be seen whether Amgen's early aflibercept launch will affect the potential market entry dates of other biosimilars. It may well remain the only Eylea biosimilar on the market for the foreseeable future: Sandoz's CEO recently suggested that the Pavblu launch "doesn't change our thinking in terms of [our] product," given that "each product has its own formulation," and "our formulation is different to Amgen's."... Global Sub. Full

Fresenius Kabi Faces Decade Wait On US Cinvanti Generic

(12/10, Dean Rudge, Generics Bulletin) ...Fresenius Kabi looks set to wait until the middle of the next decade to launch its proposed US generic version of Heron Therapeutics' Cinvanti (aprepitant) injectable emulsion for chemotherapy-induced nausea and vomiting, after falling to the originator in patent-infringement proceedings... Global Sub. Full

Biogen Expects 50% Royalty Cut After Ocrevus Biosimilars Enter Market

(12/10, Urte Fultinaviciute, Generics Bulletin) ...Biogen will take a big royalty cut for the multiple sclerosis drug Ocrevus (ocrelizumab) after biosimilar rivals enter the market, said executive vice president and chief financial officer Michael McDonnell. "Per the contract, there would be a 50% cut to the tiered royalty structure upon the approval of the biosimilars," he said during a recent Evercore HealthCONx Conference, referring to an agreement with Genentech... Global Sub. Full

Mylan's Bid to Escape EpiPen-Price Antitrust Case Gets Rejected

(12/10, Katie Arcieri, Bloomberg Law) ...Judge Daniel D. Crabtree of the US District Court for the District of Kansas in a Monday order denied Mylan's bid for partial judgment on the pleadings, saying the plaintiffs' complaint plausibly alleged that the company participated in a reverse payment to delay the launch of a cheaper generic version of the EpiPen. The ruling is a setback for Mylan, which has been trying for years to shake off claims in a wide-ranging dispute over the increasing price of the injectors that treat severe allergic reactions... Sub. Req’d

Cases of Severe RSV in Two Moderna Vaccine Candidates' Trials Raise Questions About Future

(12/10, Zachary Brennan, Endpoints News) ...Ahead of an advisory committee meeting later this week, the FDA revealed that all studies for RSV vaccines in young children and infants are currently on hold, including two not previously disclosed by Moderna. The FDA said Tuesday that it observed "an imbalance in severe/very severe cases of RSV" lower respiratory tract infections (LRTI) in both of Moderna's candidates, known as mRNA-1345 and mRNA-1365, the former of which was discontinued in September for infants... Full

Pharmacies Prevail in Appeal of $650-Million Opioid Award in Ohio

(12/10, Nate Raymond, Brendan Pierson, Reuters) ...Ohio's top court ruled on Tuesday that pharmacy chain operators CVS, Walmart and Walgreens could not be held liable for fueling an opioid epidemic in two Ohio counties that won a $650.9-million judgment against them... Full

Walgreens Is in Talks to Sell Itself to Private-Equity Firm Sycamore Partners

(12/10, Cara Lombardo, Lauren Thomas and Anna Wilde Mathews, The Wall Street Journal) ...Walgreens Boots Alliance and Sycamore Partners have been discussing a deal that could be completed early next year, assuming talks don't fall apart, according to people familiar with the matter... Sub. Req’d

Lilly CEO Says Tax and Regulation Reform, Drug Affordability Are Focuses Under Trump

(12/10, Patrick Wingrove, Reuters) ...[Eli Lilly CEO David Ricks] said the regulatory situation in the U.S. had evolved in a negative way for the pharmaceuticals industry over the last four years. "My experience having done this for eight years is there's often more common ground than you think," said Ricks, who has been CEO of Lilly since 2017. Ricks said that the Trump administration may raise the policy argument that other developed countries should pay more for drugs, and then prices in the U.S. can be lowered... Full

Medicare Plans Continue Trend of Restricting Generic Drugs

(12/10, AAM) ...Avalere has analyzed Plan D sponsors and the distribution of generic prescription drugs on the various tiers from 2016 to 2025. Over this time, the percentage of generic prescription drugs placed on Medicare Part D generic tiers has declined from 65% in 2016 to 43% in 2025. Not only can this result in higher costs for patients, but placement of generics on brand tiers can result in beneficiary confusion... Full

Guthrie Set To Bring Critical Eye To FDA, Other Agencies As E&C Chair

(12/10, Jessica Karins, InsideHealthPolicy) ...Rep. Brett Guthrie (R-KY), the next leader of the House Energy & Commerce Committee, is set to continue the committee's focus on health agency oversight, limiting regulations and spurring competition in the upcoming Congress, largely continuing the approach of the previous chair, who sought to rein back implementation of the Inflation Reduction Act and CMS' use of restrictive national coverage determinations, and has urged the incoming administration to follow a new pathway on artificial intelligence oversight... Sub. Req’d

Trump Picks Andrew Ferguson to Lead Federal Trade Commission

(12/10, Cecilia Kang, David McCabe, The New York Times) ...President-elect Donald J. Trump on Tuesday named Andrew Ferguson to lead the Federal Trade Commission, installing a current Republican member of the agency who has promised to ease up on the policing of powerful American companies — except for the biggest technology firms... Sub. Req’d

Health Tech Company Sues HHS for Rejection of Drug Rebate Model

(12/10, Nyah Phengsitthy, Bloomberg Law) ...Kalderos Inc., is urging a federal court to reject a health agency's decision that prohibits Eli Lilly & Co. from using its system to discount medicines through a rebate model under the 340B Drug Pricing Program... Sub. Req’d

Florida's Canada Drug Importation Plan Has Yet to Launch

(12/10, Phil Galewitz, KFF Health News) ...But nearly a year since the Food and Drug Administration green-lit the state's importation strategy, Florida has no planned date to begin bringing drugs over the border, according to a state official familiar with the program who asked not to be identified because they weren't authorized to speak publicly... Full

Calls for Less Bureaucracy, More Cooperation to Promote EU Pharmaceutical Competitiveness

(12/11, Filip Ác, Euractiv) ...Europe must find tangible solutions allowing it to achieve its potential as a global leader in the life sciences sector. This message resounded throughout EFPIA's healthcare conference in Brussels this week, where competitiveness and innovation were seen as central to sectoral success... Full

Pharmacy Benefit Managers: Driving Cost Savings and Innovation in Healthcare

(12/10, Canada Drugs Direct) ...Prices for Rx drugs are capped in Canada unlike in America, among other factors that go into prescription drugs costing less in Canada. US corporate healthcare plan providers can obtain even lower prices on Rx meds when they have a central fill pharmacy in Canada that is serving as their pharmacy business manager...Broadening their horizons beyond the USA may be advisable for plan admins tasked with finding cost savings. Online pharmacies in Canada with the capacity to serve as a pharmacy business manager may be able to step in and help with that... Full

Political Shifts Shake Up Japan Price Cut Debate

(12/11, Lisa Takagi, Pink Sheet) ...There is renewed political debate in Japan on whether to continue the "mid-year price cuts" between regular revisions, a scheme started in 2021. The more frequent annual reductions have been criticized for adversely affecting companies and stable medicine supplies, while leading to drug gaps with other countries. After the LDP lost its Lower House majority in the recent general election, opposition parties are increasing the pressure to move away from annual cuts... Global Sub. Full

Govt Mulls Over Generic Drugs to Rein in Costs, End Monopoly

(12/11, Ragananthini Vethasalam, The Star) ...Noting the uncontrollable rise in the cost of medicine, the monopoly of some drug companies will be cancelled and the use of generic medication will be considered to control the said costs, says Datuk Seri Anwar Ibrahim. The Prime Minister said drug purchases over the years have resulted in a monopoly and because of this, the government will be cancelling the commitment of one or two companies... Full

Indian Pharma Companies Set to Make Further Progress in US Market in 2025: HSBC

(12/11, IANS) ...Indian pharmaceutical companies, which benefited from sector tailwinds such as stable generic pricing and shortage-led opportunities and stable costs of raw materials in the past 18-24 months, will make further progress in differentiated and complex generics in the US market in 2025, a report showed on Wednesday... Full

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