Friday, June 21, 2024

Regeneron Proves Insurmountable As Second FDA Approved Eylea Biosimilar Blocked

(6/21, Dean Rudge, Generics Bulletin) ...Regeneron's lynchpin US formulation patent for its Eylea 2mg appears to remain a thorn in the side for biosimilar sponsors, as Samsung Bioepis joins Biocon in being blocked from launching its US FDA-approved biosimilar to the near $6bn eye-disease biologic...Weighing the implications of the latest injunctive relief granted to Regeneron, Morgan Stanley observed that subject to immediate appeal, the preliminary injunction is expected to remain in effect until the court hears and decides the overarching patent-infringement case, which it believes will likely not happen until the end of 2025 or even in 2026... Global Sub. Full

Samsung Bioepis to Seek Pause of Order Blocking Eylea Biosimilar

(6/20, Christopher Yasiejko, Bloomberg Law) ...Samsung Bioepis Co. wants to pause the preliminary injunction a West Virginia federal court issued last week blocking its biosimilar of Regeneron Pharmaceuticals Inc.'s blockbuster Eylea while Samsung's appeal plays out, according to court filings. The Samsung Biologics Co. unit revealed its intention in a motion for permission to file the emergency bid under seal, filed Wednesday in the US District Court for the Northern District of West Virginia. Chief Judge Thomas S. Kleeh granted the request Thursday afternoon... Sub. Req'd

Takeda Gives Sun Pharma, Cipla Rights to Commercialize Gastro Drug in India

(6/21, Navamya Ganesh Acharya, Reuters) ...Japan's Takeda Pharmaceutical gave India's Sun Pharmaceutical and Cipla the rights to commercialize gastrointestinal drug Vonoprazan in the country. The drug, which is sold in the form of tablets under the brand name 'Voltapraz', blocks a key step in the production of stomach acid, Sun Pharma said on Friday. Cipla announced the agreement late on Thursday... Full

AbbVie's Rising Star Skyrizi Nabs Key Ulcerative Colitis FDA Approval

(6/20, Zoey Becker, Fierce Pharma) ...AbbVie's fast-growing Humira successor Skyrizi is already on a roll with skyrocketing sales..."Given their 2030 drug expiries, these drugs are estimated to not only bolster sales for an extended period of time but […] are [also] poised for long-term sales growth, enabling the company to not only financially recover from Humira's expiry but to also continue its position as a formidable player within the immunology therapy area," GlobalData pharma analyst Jasper Morley said in the report... Full

J&J's Subcutaneous Version of Tremfya Excels in Crohn's Disease Study

(6/20, Kevin Dunleavy, Fierce Pharma) ...In May, Johnson & Johnson touted the success of its intravenous (IV) formulation of Tremfya in two head-to-head trials against its own Stelara in Crohn's disease. A month later, a subcutaneous (SC) version of Tremfya has excelled as an induction therapy in a phase 3 Crohn's disease study...Tremfya's emergence is timely as J&J is girding for the loss of exclusivity of Stelara, which accounted for $10.9 billion in sales in 2023, which was 13% of the company's total revenue. Stelara biosimilars are on their way this year in Europe and U.S. copycats are expected to be available early next year... Full

Industry Groups Back Drugmakers' Appeal in Zantac Cancer Lawsuits

(6/20, Brendan Pierson, Reuters) ...A bid by GSK and other drugmakers to stop more than 70,000 lawsuits in Delaware over discontinued heartburn drug Zantac has received the backing of leading U.S. industry groups, including the United States Chamber of Commerce and Pharmaceutical Research and Manufacturers of America. In a friend-of-the-court brief posted to the Delaware Superior Court's docket on Thursday, the groups said that a Delaware judge's recent ruling allowing the lawsuits to proceed jeopardized the state's business-friendly reputation and threatened to turn it into "a hotbed of products-liability and mass-tort litigation."... Full

Doctors Without Borders is Closing its Widely Regarded Access-to-Medicines Campaign

(6/20, Ed Silverman, STAT Plus) ...The organization plans to close its campaign by the end of this year and create a new effort devoted to access to products for health care. But unlike its access-to-medicines campaign, the new structure will primarily focus on products — medicines and vaccines — that Doctors Without Borders expects to need for its own relief efforts. A strategic plan for the new structure is not finalized, though, according to sources... Sub. Req'd

Telehealth Company Accused of Being Pill Mill for Adderall Says It Will Continue Treating Patients

(6/20, Matt Novak, Gizmodo) ...Done Global, the online healthcare company that saw two executives arrested last week, issued a statement this week assuring patients it will do its best to continue operations despite the federal indictments by the U.S. Department of Justice. The executives were charged with providing "easy access" to Adderall and other stimulant medications to treat ADHD and submitting "false and fraudulent claims for reimbursement."... Full

FDA Draft Guidance Removes Switching Study Requirements for Biosimilar Interchangeability

(6/20, Skylar Jeremias, The Center For Biosimilars) ...The FDA issued draft its guidance on requiring switching study data to approve a biosimilar with interchangeability, citing new science that suggests that these data are not needed to establish the safety of switching to or from a biosimilar to another product of the same molecule... Full

FDA Makes it Easier for Biosimilars to Obtain Interchangeability Designations

(6/20, Zachary Brennan, Endpoints News) ...That shift will save biosimilar developers millions of dollars in conducting the switching studies, with the FDA even explaining that biosimilar applications that are pending can be updated with the new analyses. The FDA said in a statement that its researchers found no differences in the risk of death, serious adverse events and treatment discontinuations among participants who switched between biosimilars and brand-name products and participants who did not switch in a recently conducted systematic review and meta-analysis... Full

AAM To FDA: Fewer Trials Needed In Biosimilars Approval Process

(6/20, Maaisha Osman, InsideHealthPolicy) ...The Association for Accessible Medicines, the lobby group for generic and biosimilar drugs, is urging FDA to simplify its approval process for biosimilars. The group says comparative efficacy studies (CES) using conventional endpoints to ensure consistent patient reactions between biologic and reference products, as well as three-way pharmacokinetic (PK) comparison studies using non-U.S. approved data to confirm drug equivalency, are often unnecessary... Sub. Req'd

The Middlemen: The Opaque Industry Secretly Inflating Prices for Prescription Drugs

(6/21, Rebecca Robbins and Reed Abelson, The New York Times) ...The Times interviewed more than 300 current and former P.B.M. employees, patients, physicians, pharmacists and other industry experts, and reviewed court documents and patient records. The investigation found that the largest P.B.M.s often act in their own financial interests, at the expense of their clients and patients. Among the findings: P.B.M.s sometimes push patients toward drugs with higher out-of-pocket costs, shunning cheaper alternatives... Sub. Req'd

The Middlemen: What to Do if You're Overpaying for Prescriptions

(6/21, Reed Abelson and Rebecca Robbins, The New York Times) ...P.B.M.s sometimes force patients to take a brand-name drug even though there's a cheaper generic version available...Even when you're taking a generic, your P.B.M. may be forcing you to pay more than it would cost if you paid for it with your own money — not using insurance — at your local drugstore or an online pharmacy. This often happens with generic drugs for chronic conditions like cancer or multiple sclerosis... Sub. Req'd

Pharmacy Closures May Get Worse, Michigan Pharmacists Association Says. Here's How You Can Help.

(6/20, Nathan Lee, ABC 13) ...The Michigan Pharmacists Association said pharmacy closures across the state may become more frequent, as drug prices continue to rise, reimbursement rates fall and critical regulatory legislation fails to be enforced. On Monday, Rite Aid announced the closure of a dozen stores across Michigan- a move researchers at the University of Pittsburgh said is not out of the ordinary...Eric Roath, the director of government affairs for the Association, said for his entire career, issues have stemmed from the middleman in pharmaceutical transactions: Pharmacy Benefit Managers... Full

The Next Drug Price Dilemma

(6/21, Hannah Green, Boston Business Journal) ...Rising drug costs have stirred a national conversation on affordability and prompted legislation like the Inflation Reduction Act. As more gene therapies are approved every year, which target very narrow patient populations, experts say more pressure than ever is on health insurers...The Business Journal spoke with advocates, pricing watchdogs, economists, health plans and the companies behind these rare disease medicines to look at why these new treatments cost so much, and, given their life-saving potential, whether we should even care about the price tag... Sub. Req'd

Boehringer Faces Skeptical Judge in US Drug Price Plan Challenge

(6/20, Nyah Phengsitthy, Bloomberg Law) ...A federal judge in Connecticut signaled doubt Thursday of a pharmaceutical company's bid to block a government drug price-setting program, pressing counsel on how the scheme compels speech or results in deprivation of the drugmaker's property. Chief Judge Michael P. Shea of the US District Court for the District of Connecticut repeatedly questioned Boehringer Ingelheim Pharmaceuticals Inc. during oral arguments on its various constitutional claims against the Biden administration's Medicare Drug Price Negotiation Program... Sub. Req'd

CBO Score Boosts Hopes for Drug Patent Bill

(6/20, Peter Sullivan, Axios) ...A new CBO score is encouraging backers of a bill to overhaul drug patents who are trying to include it in a year-end health deal...The bipartisan measure from Sens. Richard Blumenthal and John Cornyn would generate about $3 billion in savings over a decade, making it a potential offset for extending telehealth flexibilities or averting Medicare physician payment cuts... Sub. Req'd

340B Drug Diversion: Sanofi Suit Seeks Evidence In Pharmacy Contracts With Hospitals

(6/20, Cathy Kelly, Pink Sheet) ...Sanofi is seeking records held by HRSA to show that dispensing of 340B-discounted drugs through contract pharmacies is the cause of widespread diversion of the products to individuals who are not patients of the prescribing entity. HRSA has resisted the company's Freedom of Information request for contracts between hospitals and pharmacies, citing confidentiality. It is unclear whether the suit will prevail because the court often sides with agencies in such disputes, according to an expert. But if nothing else the complaint succeeds in portraying HRSA as ‘hiding behind' FOIA to ‘gloss over' its lack of enforcement... Sub. Req'd

Drugmakers, Compounders at Odds Over FDA's Difficult-to-Compound Rule

(6/20, Ferdous Al-Faruque, Regulatory Focus) ...Drugmakers laud the US Food and Drug Administration's (FDA) proposed rule on drugs that are difficult to compound by pharmacies and outsourcing facilities. Compounders, on the other hand, argue that the agency failed to follow rulemaking requirements and that the rule will negatively impact smaller outsourcing facilities... Full

Anti-Globalism Policy Cannot Stifle International Cooperation, US FDA's Califf Says

(6/20, Derrick Gingery, Pink Sheet) ...The FDA commissioner said that supply chains will remain interconnected no matter how much nationalism dominates the political landscape, meaning international cooperation will still be necessary...The most prominent anti-globalization legislation that would impact the pharma industry has hit a roadblock in the US House... Sub. Req'd

China Controls Much of America's Drug Pipeline. We Must Support Domestic Production | Opinion

(6/21, Kevin Cook, Idaho Statesman) ...As tensions with China continue to rise, especially over trade and sensitive technological theft, it is critical that one facet of our national security – our health – is protected. The Chinese government has designated biotechnology (and drug manufacturing) as a top priority industry for its "Made in China 2025" initiative. The United States must respond in kind by bolstering its own domestic prescription drug production for the health and safety of the American people... Full

Colorado Governor Signs Downsized PDAB Orphan Drug Bill

(6/20, Luke Zarzecki, InsideHealthPolicy) ...Colorado Governor Jared Polis (D) signed a bill into law this month that would require the state's prescription drug affordability board (PDAB) to consider input from the Colorado rare disease advisory council in determining which drugs are unaffordable for patients in the state and in setting potential payment limits. The new state law comes after a pared- back version of a bill would have nixed the board from considering orphan drugs all together... Sub. Req'd

Another Michigan Healthcare Bailout?

(6/20, Mike Kowall, RealClearHealth) ...Before the legislative session concludes on June 27, some Michigan lawmakers are working overtime to ram yet another healthcare giveaway through the statehouse...The legislation in question, House Bill 5350, will expand 340B, a program that has for years given drugs to certain hospitals serving low-income Americans at sharply discounted prices. HB 5350 doubles down on a program rife with waste, fraud and abuse. It won't help a single vulnerable Michigan receive the care they need. It will just allow very profitable hospitals and pharmacies to further line their pockets at the great people of Michigan's expense... Full

EU Pharma Reform Talks Heat Up As Health Ministers Prepare To Challenge Proposals

(6/20, Ian Schofield, Pink Sheet) ...The Council of the EU will discuss the pharma reform package on June 21, with a focus on the proposals for modulating the regulatory data protection and market exclusivity (ME) periods. The presidency of the council has suggested some changes with regard to the European Commission's original proposals and the European Parliament's April amendments that could complicate negotiations between the institutions... Sub. Req'd

Massive Stockpiling of Medicines Increases Patient Risks, Warns EU Coalition

(6/20, Aneta Zachová, Euractiv) ...Ahead of the Health Council of the EU meeting on June 21, Czechia, Cyprus, Malta, Romania, Slovakia, and Slovenia signed a non-paper emphasising the detrimental impact of excessive national stockpiling on the EU's single market and solidarity principles. The signatories acknowledge the right of individual countries to safeguard their populations by securing medicine supplies, but caution that these measures, if taken to extremes, can disrupt the balance within the EU... Full

Czechia Slams Germany Over Drug Stockpiling

(6/19, Mari Eccles and Giedre Peseckyte, Politico) ...Governments' "stupid" strategies to stockpile medicines will lead to drug shortages in other EU countries this winter, Czechia's Deputy Health Minister Jakub Dvorácek warned, as he called out Germany over its requirement...Czechia, alongside Romania, Cyprus, Malta, Slovenia and Slovakia, will use a meeting of health ministers on Friday to push for countries to reconsider their national strategies and ask the European Commission to analyze whether the measures are compliant with EU law... Full

UK Drugmakers Repeatedly Violating Marketing Code, Shows Research

(6/21, The Pharma Letter) ...New data analysis by University of Bath, UK, and Lund University, Sweden, academics reveals that public health in the UK could be undermined by a failing system of drug company self-regulation. The research shows that drug companies are consistently violating their industry code of practice in drug marketing. Not only are the code violations pervasive, but a fifth of the cases involve code violations that have been branded as "severe" by the industry's self-regulatory body... Sub. Req'd

72 Medications Used in France Suspended Due to ‘Irregularities'

(6/20, Hannah Thompson, The Connexion) ...Health authorities in Europe have suspended the sale of 400 generic medications - including 72 sold in France - due to doubt over their ‘reliability'...The EMA made the announcement after it emerged that an independent Indian company called Synapse Labs had tested all of them before they went on the market...The EMA has said that the studies done by Synapse Labs are "erroneous". Among the 72 drugs concerned in France are generics made by pharmaceutical companies Viatris, EG Labo, Sandoz, Biogaran, Teva, and Arrow... Full

Johnson & Johnson Blueprints €125M Plant Upgrade as Part of 5-Year Italy Investment

(6/20, Fraiser Kansteiner, Fierce Pharma) ...Over the next five years, J&J Innovative Medicine, which recently rebranded from Janssen, will plug a projected 580 million euros ($621.7 million) into its Italian business, the company said in a press release...The company's investment plan is set to boost capacity by more than 25% thanks to the implementation of an automated Flex Line platform to streamline packaging of small batches and a new continuous manufacturing line that J&J says will help slash production timelines... Full

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