Wednesday, March 6, 2024

Sandoz Wins FDA Approval for First Two Biosimilars for Amgen's Blockbuster Bone Drug

(3/5, Zachary Brennan, Endpoints News) ...Sandoz said Tuesday that the FDA signed off on two of its biosimilars to Amgen's bone drug denosumab. But as with other high-profile biosimilar approvals, it's unclear when either of the two new products might launch and how low prices may fall... Full

Low-Cost Versions of Humira, The Nation's Top-Selling Drug, Are Off to a Sluggish Start

(3/5, Robert Weisman, The Boston Globe) ...Nine rival drug makers piled into the market, offering what are essentially generic versions of Humira, an anti-inflammatory treatment developed in a Worcester research lab. Most of the alternatives were priced at a discount of 85 percent below Humira's list price of $84,000 a year. But a year after the first low-cost substitute became available, AbbVie still controls more than 98 percent of prescriptions for the injectable drug, according to data compiled by the Forian analytics firm... Sub. Req'd

Biosimilars Forum Sees Lessons Being Learned From US Humira Experience

(3/5, David Wallace, Generics Bulletin) ...In an interview with Generics Bulletin, Julie Reed, executive director of the US Biosimilars Forum, says that the low uptake for Humira rivals in the US has "raised everyone's attention to what is going on and what is wrong with the system."...With Reed speaking just weeks after Teva and Biocon Biologics joined the Biosimilars Forum – following Amneal and Meitheal also coming on board late last year – she also emphasized the importance of the association's membership in driving its goals. "We're honored," she said. "Teva, Biocon, Amneal and Meitheal all joined the Forum and they're all incredible biosimilar companies with very unique stories. That's really exciting. So it's really an honor and I think it's representative of the Forum's ability to be the voice of the industry."... Global Sub. Full

Roche, Alnylam Say Blood Pressure Drug Succeeds in Mid-Stage Trial

(3/5, Ludwig Burger, Reuters) ...Roche and partner Alnylam said on Tuesday their experimental drug against high blood pressure was shown to work when used in combination with the standard of care in a phase 2 trial... Full

After Tough Rightsizing, Biogen Looks to Newer Rare Diseases to Broaden Lens

(3/5, Max Bayer, Fierce Biotech) ..."On a personal level, it is tough and we just have to admit that," Keeney, Ph.D., said in an interview with Fierce Biotech at Biogen's Cambridge, Massachusetts, headquarters. "Unfortunately, it's just fiscal responsibility that if your top line is not growing, you've got to right-size the organization." Though the cost-savings plan is in the rear view, transactions are not, Keeney says. Biogen's past decade or so has largely been defined by Alzheimer's disease—for better (see Leqembi) or worse (see Aduhelm). The company's curiosity now centers on rare diseases, even ones outside of neuroscience... Full

How A Health-Care Cyberattack May Affect Your Prescription Drug Access

(3/5, Marlene Cimons, McKenzie Beard and Teddy Amenabar, The Washington Post) ...A cyberattack on a health-care company has created problems for many patients trying to fill drug prescriptions. For some consumers, the hack has forced them to pay cash for expensive drugs, denied their use of pharmaceutical discount coupons or left them unable to get their refills at all...We spoke to experts about the hack and whom it has hurt. Here's what they had to say... Full

Serve You Rx Joins Forces With Mark Cuban Cost Plus Drug Company To Enhance Prescription Affordability For Members

(3/5, Serve You Rx) ...Serve You Rx, a full-service pharmacy benefit manager with an unwavering commitment to clients, is integrating Mark Cuban Cost Plus Drug Company, PBC into its network. This collaboration increases affordable home delivery options for Serve You Rx members. With flexibility and adaptability central to Serve You Rx's identity, the company actively seeks solutions that fuel positive change for its clients and their members. Cost Plus Drugs' innovative prescription pricing model aligns with Serve You Rx's core values of transparency and quality... Full

America's Largest Generic Drug Supplier Aurobindo Is in Deep With China's Military

(3/5, Michael Stumo, The Washington Times) ...The uncomfortable truth is that Aurobindo Pharma has become America's largest supplier of generic drugs. That in itself should be problematic since Aurobindo's factories in India have frequently been cited by the Food and Drug Administration for unsafe manufacturing practices. But now we're seeing something more disturbing: Aurobindo relies on suppliers in China that have been sanctioned by the U.S. government for connections to both human rights violations and China's military... Full

Medicare Part D: Over Half Of Generics Are Still Placed On More Costly Tiers

(3/5, Urte Fultinaviciute, Generics Bulletin) ...More than half of all generics are still placed on non-generic Medicare Part D plan tiers, finds consulting firm Avalere in its latest analysis, which was funded by the American off-patent group Association for Accessible Medicines..."Medicare Part D plans continue to deny patients the full value of low-cost generic drugs. Plans are profiting from patients using generic drugs through higher copays and placement on brand formulary tiers, even as generic prices continue to fall," said David Gaugh, interim president and CEO of AAM... Global Sub. Full

Biden Is Right. The US Generally Pays Double That of Other Countries for Rx Drugs.

(3/6, Samantha Putterman, PolitiFact, KFF Health News) ...Research has consistently found that, overall, U.S. prescription drug prices are significantly higher, sometimes two to four times as high, compared with prices in other high-income industrialized countries. Unbranded generic drugs are an exception and are typically cheaper in the U.S. compared with other countries..."The available evidence suggests that the U.S., on average, has higher prices for prescription drugs, and that's particularly true for brand-name drugs," said Cynthia Cox, director of the Peterson-KFF Health System Tracker, which tracks trends and issues affecting U.S. health care system performance... Full

Drug Price Negotiations Could Discourage Additional Approvals: Study

(3/6, Adrianna Nine, BioSpace) ...Though the Inflation Reduction Act ostensibly aims to help millions of Americans by reducing prescription drug prices, the law might unintentionally discourage pharmaceutical companies from pursuing post-approval small molecule drug research, according to a study published in The American Journal of Managed Care last month. This, the authors suggest, could reduce a given medication's odds of being studied and approved as a treatment for conditions other than its initial purpose... Full

Column: A Trump Judge Slaps Down Big Pharma's Attack On Biden's Drug Price Cuts

(3/6, Michael Hiltzik, Los Angeles Times) ......"Understandably, drug manufacturers like AstraZeneca don't like the IRA," wrote Judge Colm F. Connolly, referring to the Inflation Reduction Act of 2022, which authorized Medicare to negotiate with drugmakers over how much it would pay for prescription drugs taken by its enrollees...But his opinion can serve as a window into how the other judges might view those lawsuits, most of which bear such strong resemblance to AstraZeneca's that they might all have been spit out by ChatGPT if it were asked to draft any industry lawsuit over any distasteful government regulation... Full

Pfizer says IRA Impact Will Be 'Modest,' Maps Out R&D Priority Changes

(3/5, Nicole DeFeudis, Endpoints News) ...Despite being an early critic of the Inflation Reduction Act, Pfizer told investors on Monday that the legislation is likely to have a "modest" impact on the company overall. Pfizer's CEO Albert Bourla was one of several pharma executives to condemn the IRA's Medicare negotiation provisions early on, calling it "negotiation with a gun to your head" in a live-streamed Reuters interview last May. But it appears that Pfizer is coming to terms with the new law... Full

Congresswoman Caraveo Leads Bipartisan Legislation to Tackle High Prescription Drug Costs

(3/5, Colorado Representative Yadira Caraveo) ...Rep. Yadira Caraveo (D-CO), the only physician to represent Colorado in Congress, along with Rep. Tracey Mann (R-KS), introduced the bipartisan Prescription Drug Supply Chain Pricing Transparency Act to require the Government Accountability Office conduct a study to increase transparency in the flawed drug pricing supply chain. "As a doctor, I was able to make a diagnosis based on my patients' symptoms. But even with accurate and timely diagnosis, patients aren't always able to get the medication they need because of high costs", said Rep. Caraveo... Full

FTC Tackles Private Equity Takeover Effects On Health Care Operations, Costs

(3/5, Gabrielle Wanneh, InsideHealthPolicy) ...Federal agencies are calling on stakeholders across the health care system to weigh in on whether a surge in private equity and other corporate ownership is lowering quality care for patients and negatively affecting myriad aspects of the health care system, including drug prices. The agencies will use the input to drive their enforcement and efforts to promote competition in health care markets... Sub. Req'd

Sen. Warren Attacks GSK's Decision to Shift Inhaler from Brand to Authorized Generic

(3/5, Zachary Brennan, Endpoints News) ...GSK's decision to switch patients from its brand-name Flovent inhaler to an authorized generic is an "insidious" tactic that "may cause millions of children" to lose access to their asthma and allergy medication, Sen. Elizabeth Warren (D-MA) said in a letter to the company released on Monday...GSK told Endpoints News that some formulations of the authorized generic cost about $100 less than the branded version. The company confirmed receipt of the letter and said it will respond to Warren... Full

Warren Rebukes GSK for Alleged 'Money Grab' After Company Pulled Popular Asthma Med

(3/5, Fraiser Kansteiner, Fierce Pharma) ...Naturally, GSK sees things differently, though a company spokesperson said over email that the company does plan to "respond directly" to Warren. The spokesperson explained that GSK elected to launch authorized generics for Flovent HFA and its sister product Flovent Diskus to help maintain patient access to the drug, potentially at a lower cost and "knowing that we had been planning to discontinue the branded products for some time."... Full

Georgia Patients Struggle to Find Drugs They Need Due to Shortages

(3/6, Michael Scaturro, The Atlanta Journal-Constitution) ...The Federal Trade Commission and the U.S. Department of Health and Human Services on Feb. 14 announced they are looking into the role of group purchasing organizations and drug wholesalers play in contributing to drug shortages, which includes drugs used to treat ADHD, cancer, and rheumatoid arthritis. In Georgia, doctors and patients say they are waiting longer for drugs or switching to alternatives. Doctors say they are managing the situation – for now – but both they and patient support groups say the situation is untenable, and are urging Congress to find a long-term policy fix... Full

HHS, Facing AHA Pressure, Takes Steps To Address Cyber Attack

(3/5, Cara Smith, InsideHealthPolicy) ...HHS on Tuesday (March 5) unveiled steps it is directly taking to help providers navigate major billing problems spurred by the recent cyber attack on UnitedHealth Group, coming after the American Hospital Association and oncologists pleaded with the Biden administration and Congress to force CMS to step in... Sub. Req'd

Smokescreen? FDA Won't Say How It Spends User Fees

(3/6, Michael Chamberlain, RealClearHealth) ...The Food and Drug Administration is funded by Congress, but it also collects "user fees" from regulated industries to fund testing and regulation of those industries' products. By law, fees from the dairy industry must be used only to ensure dairy products are safe – they can't go toward overseeing the safety of cold medications. Of course, agencies can still spend the funds on a range of permissible activities related to the industry's activities... Full

Florida Gets the OK. But Will Drug Importation from Canada Actually Happen?

(3/5, Susan Ladika, Managed Healthcare Executive) ...Florida has become the first state to receive approval from the FDA to import certain prescription drugs from Canada, with the aim of lowering costs. However, some experts are skeptical that the medications will ever make it across the border. "I don't think Canada has any interest in this occurring," says Randy Hatton, Pharm.D., a clinical professor at the University of Florida College of Pharmacy in Gainesville. It's likely in Canada's "best interest to maintain their own pharmaceutical supply chain," he adds... Full

West Virginia Senate Bill to Help Reign in PEIA Drug Prices Stalls in House

(3/5, Mark Curtis, WOWK) ...With just a few days left in the legislature, there is a real push at the 11th hour to save West Virginia millions of dollars on what it pays for prescription drugs for state employees. Right now, the bill appears stalled in the House Finance Committee, but supporters are not giving up. Fruth Pharmacies President Lynne Fruth was throwing a one-woman informational protest inside the Capitol Rotunda. It was back in January when Fruth told us that she had uncovered disparities in what PEIA pays for drugs. A large national chain might be paid $600, while Fruth might only be paid half of that for the very same prescription and dosage. Fruth wants the House to pass Senate Bill 453, which would reign in Pharmacy Benefits Managers, known as PBMs, who negotiate prices... Full

Biotechnology Trade Groups Urged Youngkin to Veto Bills Creating a Prescription Drug Affordability Board in Virginia

(3/5, Tyler Englander, WAVY) ...All eyes are on Gov. Glenn Youngkin as some stakeholders are urging him to veto bills to create a board that would review the cost of certain prescription drugs. Two bills, one in the House and one in the Senate, would create a Prescription Drug Affordability Board for Virginia...However, not everyone thinks the board is a good idea. The Virginia Biotechnology Association sent a letter to Youngkin urging him to veto the bills, saying they would "stifle necessary investments in continued research and development, threatening the ability of Virginia biotechnology companies to bring new medicines to market."... Full

Oregon Drug Prices in the Spotlight as Legislative Session Nears End

(3/5, Jake Thomas, The Lund Report) ...The three bills delve into an ongoing tug-of-war in which insurers are trying to limit their drug expenses — such as by discouraging pharmaceutical companies from pushing patients toward costly patented drugs when generics might suffice. In all three cases, lawmakers are siding with advocates who say the impacts on patients or providers are unacceptable... Full

For Generics, EU Reference Product Is Non-Negotiable – Even In Pilot On Parallel Advice

(3/5, Urte Fultinaviciute, Pink Sheet) ...Acknowledging that it may be a barrier to some extent, EMA's senior scientific specialist of clinical pharmacology Kevin Blake notes that EU reference medicinal products are a legal requirement for bioequivalence studies and cannot be circumvented...During the Q&A session, he acknowledged that this may be a barrier to some extent, but it simply cannot be negotiated... Sub. Req'd

AIRIS 2024: Global Cooperation A Challenge For Regulation Of AI Products

(3/5, Jung Won Shin, Pink Sheet) ...During the first international symposium on the use of AI in medical products, co-hosted by US and Korean regulators, global experts discussed issues and challenges related to effective development and regulation. Cooperation, flexibility and the need for a "human-centric" approach emerged as key themes in the fast-moving field... Sub. Req'd

European Commission Spells Out New Proposals for Health Technology Assessments

(3/5, Lia DeGroot, Endpoints News) ...The European Commission is encouraging member countries to work together more effectively on assessing and paying for new therapies and health technologies with a proposal it published Tuesday. The 18-page proposed rule sets out to establish practices to ensure that EU-level assessments of new products are efficient and done with the relevant expertise. The EC is accepting comments on the draft rule until April 5... Full

European R&D Industry Warns SPC Proposals Could Cause Delays & Invite Abuse

(3/5, Ian Schofield, Pink Sheet) ...A pre-grant opposition mechanism would introduce uncertainty into the existing supplementary protection certificate framework and would be open to abuse by third parties seeking to exploit gaps in the protection of originator drugs, according to EFPIA and the Chartered Institute of Patent Attorneys... Sub. Req'd

UK's MHRA Approves First Drug Under International Recognition Procedure

(3/5, Joanne S. Eglovitch, Regulatory Focus) ...The UK Medicines and Healthcare products Regulatory Agency recently approved Amgen's bone cancer drug Xgeva (denosumab), the first drug submitted through the international recognition procedure. The IRP, which was launched on January 2, aims to streamline the approval of new medicines that have been approved by other "trusted" regulators, yet the MHRA retains the ultimate approval authority. IRP replaces the EC Decision Reliance Procedure, according to an MHRA Notice. The new procedure stemmed from the UK's withdrawal from the EU through Brexit... Full

FDA-EMA Parallel Scientific Advice Program For Complex Generics Could Add Health Canada

(3/5, Derrick Gingery, Pink Sheet) ...The FDA-EMA parallel scientific advice program for complex generics soon could add another regulator, which may increase the appeal of the meeting process intended to streamline patient access to the products. Health Canada is interested in joining the group, which would make the trilateral PSA meetings (US Food and Drug Administration, European Medicines Agency, and sponsor), potentially quadrilateral... Sub. Req'd

Canada Considers Joining FDA-EMA Complex Generic Advice Scheme, But Is It Working?

(3/5, Urte Fultinaviciute, Generics Bulletin) ...Health Canada is open to the collaborative effort but is still in "preliminary discussions," while the FDA and EMA try to attract more applicants to the parallel scientific advice pilot scheme for complex generics...Lei Zhang, deputy director at the Office of Research and Standards within the Office of Generic Drugs at the FDA, said that the low numbers may also be explained by the limited number of applicants who submit generic drug applications both to the FDA and via the centralized EMA process... Global Sub. Full

Amgen Introduces Second Stelara Rival In Canada

(3/5, David Wallace, Generics Bulletin) ...Amgen has launched its Wezlana rival to Stelara in Canada, following up on Jamp and Alvotech's recent partnered launch of the first Canadian ustekinumab biosimilar, Jamteki, with what Amgen has billed as "the first biosimilar to Stelara to be available for Canadian patients in all indications."...The battle between Amgen and Alvotech's Stelara biosimilars in Canada could be seen as a precursor to the firms facing off in the US in early 2025...Alvotech and US marketing partner Teva have secured a launch date just a few weeks after Amgen – "no later than February 21, 2025" – and Alvotech is not only expecting FDA approval next month but also believes that it may be eligible for an interchangeability designation of its own just a couple of months after launch, in April 2025... Global Sub. Full

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