Friday, September 13, 2024

Regeneron Sets Out Timing Expectations For Dupixent Biosimilars

(9/13, David Wallace, Generics Bulletin) ..."I'm not an attorney, but I've been handling all the patent questions," [Regeneron's senior vice president of investor relations and strategic analysis, Ryan Crowe,] acknowledged. "The composition of matter patent – which is typically the strongest patent in a patent estate – for dupilumab, expires in March of 2031." However, he added, "we have several other pending and issued patents that span formulations, methods of treatment using dupilumab and even manufacturing that reach into the early to mid-2040s. And we're certainly going to assert those and defend those patents, though we would expect them to be litigated."... Global Sub. Full

US FDA Biologics Designation As Price Protection: Lilly Charts New Course With Retatrutide

(9/12, Cathy Kelly, Pink Sheet) ...Eli Lilly and Company's recently filed lawsuit against the US Food and Drug Administration seeking to overturn the agency's refusal to designate the company's investigational obesity agent retatrutide a biologic may forge a new path toward extended market exclusivity and unfettered pricing...By seeking to reverse the FDA's judgement, the suit attempts to leverage the newly created opportunity offered by the Supreme Court's June decision in Loper v. Bright, which overturned the Chevron doctrine of court deference to federal agencies... Sub. Req’d

Baltimore's Opioid Case Could Head to Court Next Week. Here's How We Got Here.

(9/13, Lee O. Sanderlin, The Baltimore Banner) ...Six years in the making, the trial will be the city's last chance to add to the massive amounts of money it has already received from other pharmaceutical companies this year as part of settlement agreements... Full

The Generics Bulletin Podcast: Recent And Upcoming Industry Events

(9/13, David Wallace, Generics Bulletin) ...This edition of the Generics Bulletin podcast sees editor Dave Wallace, deputy editor Dean Rudge and reporters Urte Fultinaviciute and Adam Zamecnik discuss recent off-patent industry events such as the legal and annual conferences held by Medicines for Europe in Dublin in June and the annual meeting of the US Association for Accessible Medicines earlier this year, while also looking ahead to the key off-patent industry events on the calendar over the next few months and beyond... Global Sub. Full

US Employers Expect Nearly 6% Spike in Health Insurance Costs in 2025, Mercer Says

(9/12, Amina Niasse, Reuters) ...Mercer said 53% of employers plan to implement cost-management changes in 2025, an increase from 44% in 2024. Those strategies would target reducing utilization by plan members with expensive conditions and managing specialty drug costs, Umland said. In 2024, prescription drug spending remained the fastest-growing cost for employers, rising 7.2% from 8.6% in 2023... Full

Senate Judiciary To Mark Up Controversial Patent Reforms

(9/12, Gabrielle Wanneh, InsideHealthPolicy) ...The Senate Judiciary Committee next Thursday (Sept. 19) will mark up bipartisan bills that would reform the rules and procedures a tribunal under the United States Patent and Trademark Office must adhere to when reviewing patent validity and would restore patent eligibility to various inventions across multiple fields -- a move that has sparked strong objections from a drug-price reform advocacy group, which says the bills could to lead to higher prices. Patients for Affordable Drugs Now (P4AD Now) is urging the committee not to pass the bills... Sub. Req’d

Why The Largest PBMs May Be Focusing on Specific Markets: Study

(9/12, Paige Minemyer, Fierce Healthcare) ...The analysis, released in the Journal of the American Medical Association, finds that CVS Health's Caremark holds the largest market share overall in the PBM space. However, it led by the largest margin Medicaid managed care, controlling 39.2% of the market... Full

Overcoming the Challenges of PBMs: Expanding Patient Access to Affordable Treatments

(9/12, Pharmacy Times) ...In an interview with Pharmacy Times® at the Community Oncology Alliance (COA) 2024 Payer Exchange, Fred Barton, PharmD, and vice president of clinical product and partnerships at AffirmedRx, explains the challenges of PBMs in the health care industry and the steps that need to be taken to promote more transparency... Full

Two Separate Reports Sound Alarm on PBM Practices That Harm Patients, Consumers

(9/12, Connie Farrow, Missouri Independent) ...It was also clear from both reports that PBMs hold substantial power over patients' ability to access and afford their prescription drugs. They noted that PBMs frequently tout the savings they provide payers and patients through negotiations, drug utilization programs and other pricing mechanisms, even though the evidence indicates they often increase costs for patients and taxpayers. Ultimately, if the rebate system functioned as it should, and as consumers are led to expect, patients would notice a reduced price for their medicine when paying at the pharmacy... Full

Medicare Drug Pricing Negotiations: What Comes Next?

(9/12, Jonah Comstock, Pharma Phorum) ...[O]n today's podcast host Jonah Comstock is joined by Alice Valder Curran, a partner at Hogan Lovells and a healthcare policy expert, for a broad ranging discussion of some of the next steps and consequences – intended or otherwise – of this legislation... Full

Generics And Biosimilars Saved US $445bn In 2023, But Industry Stands At ‘Critical Crossroads'

(9/12, Urte Fultinaviciute, Generics Bulletin) ..."We cannot afford to take our generic and biosimilar industries for granted. We must do better!" encouraged David Gaugh, interim president and CEO of the Association for Accessible Medicines, as the organization released its 2024 US Generic and Biosimilar Medicines Savings Report. This was the report's overarching message, "highlighting the overall value of the generic and biosimilar industry" but also flagging the biggest pain points that the off-patent industry is facing... Global Sub. Full

FDA Seeks Input on Its Innovative Manufacturing Technology Strategy

(9/12, Joanne S. Eglovitch, Regulatory Focus) ...Stakeholders have previously raised concerns about long review times for their products by the ETT and CATT. They have also cited differing international regulatory requirements affecting innovative manufacturing technologies as a hurdle to their adoption. To address these concerns and to bolster industry adoption of innovative manufacturing technologies, FDA laid out several steps it plans to take in the draft strategy document... Full

FDA Revisits New Structure for Drug Review Documents, Aiming to Better Explain Its Decisions

(9/12, Zachary Brennan, Endpoints News) ...On Thursday, the FDA sought additional comment on the integrated reviews documentation, which has already been implemented for new molecular entities, original biologic applications, and select efficacy supplements, and is coming soon for other products... Full

Newest Chapter in the Nitrosamine Saga – A Revised Guidance and FDA Acknowledges Their Differences

(9/12, Jennifer Leaming, Lachman Consultants) ...Now that we've all had more time to carefully read and absorb the updates in the revised, overarching nitrosamine guidance, it seems that the oft-discussed global harmony on this topic is still no closer to reality... Full

Vermont Senator Introduces Bill to Strengthen 340B Protections for Drug Access

(9/12, Akosua Mireku, Pharmaceutical Technology) ...Peter Welch, the senator for Vermont, criticised manufacturers for placing restrictions on the 340B drug pricing programme which provides financial help to US hospitals to allow communities to access prescription drugs amid rising costs... Full

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