Thursday, August 22, 2024

Generic Weight-Loss Drugs Won't Come for Years

(8/22, Bill Alpert, Barron's) ...Guggenheim analyst Seamus Fernandez checked what some of the big generic drugmakers have been saying about the booming GLP-1 category. Many are making plans, but according to the analyst's Aug. 16 note, Novo and Lilly won't face substantial competition in the U.S. or Europe until the early 2030s. The big generic firm Teva Pharmaceutical Industries already launched the first GLP-1 generic, an injectable drug known as liraglutide, at the end of June. It's a generic version of a first generation GLP-1 that Novo launched years ago, under the names Victoza and Saxenda. Other generic makers will follow with liraglutide launches this year... Sub. Req'd

Sesame to Offer Compounded Semaglutide 'At Cost' As Weight Loss Drug Competition Heats Up

(8/21, Heather Landi, Fierce Heatlhcare) ...As the weight loss drug market grows, some virtual care players seem to be competing on price. Sesame unveiled on Wednesday its Success by Sesame clinical, direct-to-consumer weight loss program. The company is making compounded semaglutide available to clinically eligible customers "at cost," with no retail price markup...The price of Sesame's program, which includes clinical oversight from a board-certified provider, is $249 per month... Full

NMPA Approves AstraZeneca's Fasenra for Severe Asthma

(8/21, Pharmaceutical Technology) ...The China National Medical Products Association (NMPA) has approved AstraZeneca‘s Fasenra (benralizumab) as a maintenance treatment for individuals aged 12 years and older with severe eosinophilic asthma (SEA)...Fasenra demonstrated a 74% reduction in the annualised asthma exacerbation rate when used alongside standard care in patients with SEA... Full

MSN Put On Hold As DC Appeals Court Freezes Generic Entresto Approval

(8/21, Dean Rudge, Generics Bulletin) ...MSN Laboratories will be unable to move forward – for now – with any potential ‘at-risk' launch for its generic version of Novartis' Entresto blockbuster in the US after the originator won a stay on the firm's ANDA pending appeal from the US Court of Appeals For the District of Columbia Circuit... Global Sub. Full

In Launching Epinephrine Nasal Spray, ARS Pharma Has a 'Blue Sky Opportunity,' Analyst Says

(8/21, Kevin Dunleavy, Fierce Pharma) ...Gaining FDA approval for its epinephrine nasal spray came nearly a year later than expected for ARS Pharmaceuticals. But after the recent approval of neffy, the San Diego drugmaker is poised for an October launch and a "blue sky opportunity," according to analysts at Leerink Partners. By offering a needle-free alternative, ARS has a chance to gain users among the 13.5 million in the United States who have been diagnosed with type 1 allergic reactions and who do not have current epinephrine prescriptions, according to a Leerink note... Full

Where Does Nasal Spray Epinephrine Fit in Allergy Treatment?

(8/20, Kristina Fiore, MedPage Today) ...That answer isn't clear just yet, experts told MedPage Today, and one expert who served on the FDA advisory committee reviewing nasal spray epinephrine cautioned that it hasn't been studied in anaphylaxis, the disorder it's intended to treat. However, none of the available epinephrine devices has been studied in such a scenario, as that trial would be difficult to do, ethically and logistically..."I would still keep my EpiPen around," [Lewis Nelson, MD] told MedPage Today. "I just don't want to create a false sense of security that we have equipoise between the devices."... Full

Lek, The Leading Provider of Biosimilar Medicines in Slovenia, Launches a New Medicine with Ustekinumab, Intended to Treat Patients with Chronic Inflammatory Diseases

(8/22, Lek) ...The new biosimilar medicine from Lek, a Sandoz company, strengthens the well-established Sandoz immunology portfolio in Slovenia and across Europe. The ustekinumab biosimilar is available in Slovenia with all reference medicine strengths. The medicine is intended to treat adults with plaque psoriasis, psoriatic arthritis, Crohn's disease and pediatric plaque psoriasis... Full

Biosimilars Have Yet to Make An Impact in Ophthalmology

(8/21, Alex Young, Healio) ..."There are many hundreds of thousands, maybe millions, of patients on biologic drugs like aflibercept or systemic ones like Humira," David A. Eichenbaum, MD, said...Uptake on biosimilars has been slow, Eichenbaum said. Some of this can be attributed to the safety concerns seen with Razumab (Intas Pharmaceuticals), which was associated with inflammation in India, as well as efficacy concerns compared with originator products... Full

Biosimilars in Oncology: Barriers to Wider Use

(8/20, Alan P. Lyss, MD, MPR) ...Though biosimilars and reference products have demonstrated similar efficacy and safety across studies, and using biosimilars can potentially cut costs, experts have cited several challenges preventing more widespread use of biosimilars in oncology. These challenges include the cost and complexity of biosimilar development, oncologists' lack of knowledge about biosimilars, and the fact that interactions between payers, manufacturers, and pharmacy benefit managers can sometimes drive up the cost of biosimilars, thereby preventing wider use... Full

The Fall and Rise of Digital Therapeutics

(8/22, Cheryl Barton, Pharma Phorum) ...DTx have been a transformative force in healthcare, providing an alternative evidence-based intervention to drugs and medical devices in the prevention, management, and or treatment of medical disorders...Several pharma DTx partnerships have been announced in recent months...In March 2024, Teva UK announced a strategic partnership with Closed Loop Medicine to use its proprietary software as a medical device (SaMD) as a digital companion to pharmaceuticals to advance the development of personalised medicines... Full

Potential Tweaks To IRA Not Enough To Quell Innovation Harms, Industry Says

(8/21, Gabrielle Wanneh, InsideHealthPolicy) ...Lawmakers on both sides of the aisle have been considering updating the Inflation Reduction Act to ensure the law's provisions offer cost savings for seniors on prescription drugs without disincentivizing the development of certain types of drugs; but the drug industry maintains that stepping away from government price controls completely is the best way to avoid a bleak future for innovation, even if pending legislation would address some of the law's issues... Sub. Req'd

Off-Patent Industry Criticizes CMS' Negotiated Price Drug List

(8/22, Urte Fultinaviciute, Generics Bulletin) ...The Association for Accessible Medicines' interim president and CEO David Gaugh said that the announced price list "only highlights the folly of this government price setting scheme." The CMS estimated that if these prices were in place last year, the country would have achieved savings of 22% from the selected brand drugs, but Gaugh called it "a figure that pales in comparison to typical savings from generics and biosimilars."... Global Sub. Full

Pharma's Concerns Pile Up Months After Supreme Court's Landmark Chevron Decision

(8/21, Amy Baxter, PharmaVoice) ...In the immediate aftermath of the decision, the shift has lobbed more uncertainty into a tough regulatory environment, which is why the pharma industry may be taking a "wait-and-see" approach in the fallout, said Jesse Mendelsohn, senior vice president at revenue management company Model N...The decision could expose even day-to-day decisions by the FDA to legal challenges. Patent issues, regulatory efforts and R&D focus are areas where the industry might have to reconsider their strategic positions, according to a report from law firm Buchanan, Ingersoll & Rooney... Full

Price Controls On Obesity Meds Is a Mistake

(8/21, Kirsten Axelsen, RealClearHealth) ...Without even seeing the results of the Inflation Reduction Act price setting, President Biden and Senator Sanders want to further expand the government's role in setting the price for medicines. Notably, they call for more government intervention in setting the price of drugs in Medicare and to use federal government power to reduce the price of the effective and popular medicines that treat obesity and diabetes. However, this call for price controls, specifically for medicines for obesity and diabetes, is based on flawed evidence and unrealistic expectations of the outcome of this type of policy intervention... Full

Lowest Price for Top Generic Drugs in US Varies Among Six Discount Programs

(8/21, Michael Monostra, Healio) ...A 90-day supply of most of the top generic drugs in the U.S. can be purchased from a discount program for $15 or less, but none of the programs consistently offer the lowest prices for generic drugs, according to two presenters...In an analysis of 90-day supply prices, Amazon had lowest price for 32% of medications, followed by GoodRx at 24% and the Mark Cuban Cost Plus Drug Company at 18%. CVS had the highest price for 42% of drugs, followed by Walmart at 38%... Full

More Employers Turning to Benefit Startups to Manage Drug Costs

(8/22, Lauren Clason, Bloomberg Law) ...More and more employers are migrating to smaller pharmacy benefit managers—which manage the prescription drug benefit of insurance plans—in an attempt to curb rising costs and comply with strengthened fiduciary duties...Forty percent of employers surveyed by the Business Group on Health are considering implementing transparent PBM models in the next two years either with the big three companies or smaller startups, according to data released Aug. 20, while 29% implemented a transparent program in 2023. Sixty-two percent are working with their current PBM on new programs in 2024 and 2025... Full

PBMs and Vertical Integration: CBO Adds To Growing Concerns About Negative Impacts

(8/21, Sarah Karlin-Smith, Pink Sheet) ...CBO says savings on drug prices generated from insurance-PBM mergers may not be getting to patients. Meanwhile, nonintegrated health plans see increased drug costs due to PBM-insurance integration. CBO comments may add to growing chorus to do more than just study integration impacts as part of PBM reform... Sub. Req'd

Expert Discusses PBM Transparency, Balancing Competition, and Real-Time Optimization

(8/21, Pharmacy Times) ...Brandon Newman, the founder and CEO of Xevant, emphasizes the importance of balanced regulation and transparency in the pharmacy industry. He cautions that proposed legislation could stifle competition and innovation if not carefully crafted, potentially leading to big PBMs exiting certain contracts. Newman argues that simply setting prices through government mandates does not necessarily achieve the desired outcomes, as manufacturers may raise prices elsewhere to compensate... Full

Biosimilars Council Submits Comments, Applauds FDA Draft Guidance Regarding Interchangeability

(8/21, Biosimilars Council) ...The Biosimilar Council appreciates and agrees with the FDA's position that data from a switching study or studies may no longer be necessary to support licensure of interchangeable biosimilar medicines... Full

ERISA Industry Committee Applauds FDA Efforts to Make Biosimilars More Accessible

(8/21, Sandra Levy, Drug Store News) ...The ERISA Industry Committee is commending draft guidance by the Food and Drug Administration, titled, "Considerations in Demonstrating Interchangeability With a Reference Product: Update Guidance for Industry." ERIC said that the Guidance will help increase competition in the prescription drug markets, boosting the availability of affordable biosimilar drugs... Full

UK Patients Unlikely to Get Access to Eisai-Biogen's Alzheimer's Drug

(8/22, Maggie Fick and Prerna Bedi, Reuters) ...Alzheimer's patients in Britain's state-run health service are unlikely to get access to Eisai and Biogen's new Leqembi drug, after it was approved on Thursday by the country's regulator but deemed too expensive for wide use... Full

U.K.'s Cost-Effectiveness Agency Gives Negative Review of Alzheimer's Drug Leqembi

(8/22, Andrew Joseph, STAT Plus) ...In draft guidance, the U.K.'s cost-effectiveness watchdog on Thursday said that the limited benefits of the drug, also called lecanemab, do not justify its costs, citing not just the price of the treatment but the related expenses of administering it and monitoring for side effects...Eisai and Biogen said they would appeal the European Medicines Agency's decision... Sub. Req'd

Indian CDMOs Unlikely to See Sudden Surge in Clients if China Bill Passes, Execs Say 

(8/21, Anna Brown, Endpoints News) ...While pharma companies might be thinking they will move out of China in the long term, the pace at which this will happen is unlikely to be as quick as expected, CiVentiChem CEO Bhaskar Venepalli told Endpoints News in an interview. Indian CDMOs have pointed to the bill's grandfather clause, the sluggish biotech funding environment and the significant effort needed to move commercial projects between continents as key factors contributing to delayed decisions... Sub. Req'd

Imports Weaken Indian Pharma

(8/22, Chetali Rao, K.M. Gopakumar, Biswajit Dhar, The Hindu) ...New medicines are generally under patent protection, preventing Indian companies from producing affordable generics/biosimilars. Meanwhile, regulatory guidelines, which impose costly and time-consuming requirements for obtaining marketing approval of biosimilars, can adversely affect domestic producers. However, both these entry barriers can be overcome through proactive government action... Sub. Req'd

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