Tuesday, May 21, 2024

Teva, Alvotech Launch Biosimilar Against AbbVie's Humira

(5/21, Dulan Lokuwithana, Seeking Alpha) ...A U.S. unit of generic drugmaker Teva Pharmaceutical Industries and Luxembourg-based Alvotech have launched Simlandi, an interchangeable biosimilar version, targeting AbbVie's blockbuster arthritis therapy, Humira...Teva and Alvotech are in talks with payers to increase accessibility for the drug. The companies plan to launch six other biosimilars by 2027... Full

Teva, Alvotech Announce Simlandi Injection Now Available in U.S.

(5/20, The Fly) ...Teva Pharmaceuticals and Alvotech, "announced the availability of SIMLANDI injection in the U.S., as an interchangeable biosimilar to Humira for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn's disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis... Full

US Eylea Biosimilar Approvals Set Up Competition On Aflibercept

(5/21, David Wallace, Generics Bulletin) ...Biocon and Biogen have received simultaneous US approvals for aflibercept biosimilar rivals to Eylea, with both products also receiving interchangeability designations. However, launches may have to wait while IP issues are resolved...Amgen late last year confirmed a filing for its own aflibercept biosimilar, with the company also engaged in litigation with the originator. And Alvotech has also recently reported positive trial data for its AVT06 candidate, on which the firm has partnered with Teva for commercialization in the US... Global Sub. Full

US FDA Approves Two Biosimilars for Blockbuster Eye Drug Eylea

(5/20, Leroy Leo and Sriparna Roy, Reuters) ...The agency approved Biocon Biologics' Yesafili as well as Samsung Bioepis and Biogen's Opuviz, while also allowing interchangeability, or the drug's substitution with biosimilars without the need for a doctor's advice. It was not immediately clear when the therapies would be launched. Regeneron has filed lawsuits against companies such as Amgen and Biocon, which are seeking to bring Eylea biosimilars to the U.S. market... Full

FDA Approves First Eylea Biosimilars

(5/20, Skylar Jeremias, The Center For Biosimilars) ...The FDA announced that it approved the first 2 biosimilars referencing Eylea (aflibercept) for the treatment of ophthalmic conditions, including neovascular age-related macular degeneration, macular edema, and diabetic retinopathy...According to data from Cardinal Health, at least 8 aflibercept biosimilars are expected to enter the market in 2024, but similar to the adalimumab and ustekinumab spaces, patent lawsuits will likely result in settlements delaying most—if not all—aflibercept biosimilar launches... Full

GSK's SWIFT Trial Anthology Shows Long-Acting Treatment Reduces Asthma Attacks

(5/21, Gabrielle Masson, Fierce Biotech) ...The pivotal SWIFT-1 and SWIFT-2 trials have shown that GSK's long-acting asthma treatment reduces attacks. Center stage is depemokimab, a biologic GSK calls "ultra-long-acting" with a binding affinity and high potency for interleukin-5...The pharma hopes depemokimab's alchemy can produce a winning streak across a range of other IL-5 mediated diseases, assessing the drug in phase 3 trials among patients with eosinophilic granulomatosis with polyangiitis, chronic rhinosinusitis with nasal polyps and hypereosinophilic syndrome... Full

GSK Experimental Drug Reduces Severe Asthma Attacks in Trial

(5/21, Ashleigh Furlong, Bloomberg) ...An experimental drug from GSK Plc reduced asthma attacks in late-stage trials, paving the way for a treatment that the British drugmaker forecasts could exceed £3 billion ($3.8 billion) in sales...GSK has said that the monoclonal antibody represents a key growth area for the company's respiratory business, which has been boosted in recent years by the asthma drug Nucala. Depemokimab is also being trialled in chronic rhinosinusitis, with data expected to come out on that indication later this year. Under Chief Executive Officer Emma Walmsley, GSK has revitalized its pipeline, and it expects at least 12 major launches from 2025 in infectious diseases, HIV, respiratory and oncology... Full

Sanofi and Regeneron Update Trial Data, Strengthening Case for Dupixent in COPD

(5/20, Kevin Dunleavy, Fierce Pharma) ...One day after AstraZeneca and Amgen presented midstage data on their biologic treatment Tezspire (tezepelumab) that missed the trial's primary objective but still showed promise in certain groups of COPD patients, Sanofi and Regeneron chimed in with an update on their versatile biologic Dupixent (dupilumab), which is closing in on a potential COPD approval... Full

‘A New Era of Growth': AstraZeneca Aims for $80B Revenue, 20 New Drugs by 2030

(5/21, Amber Tong and Reynald Castañeda, Endpoints News) ...In what CEO Pascal Soriot described as "a new era of growth," the UK pharma said it is targeting $80 billion in total revenue by 2023, which is 75% higher than what it raked in last year at $45.8 billion, according to a Monday press release ahead of its Investor Day in Cambridge, UK...In its 2030 mission, AstraZeneca said it will broaden its existing oncology, biopharma and rare disease footprint. It is also looking to launch 20 new drugs by 2030, with certain assets potentially pulling in $5 billion in peak sales... Full

AstraZeneca Aims for $80 Bln in Total Revenue by 2030

(5/21, Yadarisa Shabong and Maggie Fick, Reuters) ...Soriot said on Tuesday that many of the new medicines the drugmaker plans to launch by 2030 have the "potential to generate more than $5 billion in peak year revenues". AstraZeneca, which is facing patent expiries on some key drugs, said it would continue to invest in new technologies and platforms that will "shape the future of medicine" beyond 2030. Analysts at Jefferies said the revenue target of $80 billion was widely expected, adding that major new drug catalysts are "somewhat scarce" until 2025 but that its "pipeline optionality remains perhaps best-in-class" for big pharma... Full

Sanofi Partners with OpenAI, Formation Bio On AI-Driven Drug Development

(5/21, Augustin Turpin, Reuters) ...French drugmaker Sanofi on Tuesday announced it is collaborating with artificial intelligence company OpenAI and Formation Bio to boost its drug development projects through the use of Artificial Intelligence. Sanofi said in a statement that the partnership with OpenAi will allow it to access proprietary data to develop AI models for its biopharma models, while Formation Bio will provide additional engineering resources... Full

Glenmark Unit Ties Up with BeiGene to Market Cancer Drugs in India

(5/21, Press Trust Of India) ...Glenmark Pharmaceuticals on Tuesday said its unit has inked a marketing and distribution agreement with BeiGene to commercialise the latter's oncology medicines, Tislelizumab and Zanubrutinib in India...Glenmark said recent statistics indicate that India has the third highest number of cancer cases worldwide, with predictions suggesting this could reach 2.08 million cases by 2040 -- a 57.5 per cent increase from 2020... Full

Drug Shortages Continue to Plague Consumers and Healthcare Professionals

(5/20, Bob Pollock, Lachman Consultants) ...Trying to comprehend these situations in a country with an (allegedly) advanced healthcare system is difficult, but here we are. So, it does not really matter whether there are 110 drug shortages as reported by one source or 254 as reported by another. If the patient cannot get the drug they need, when they need it, either through their pharmacy, healthcare system, or healthcare provider, the result is a drug shortage! Work continues to be done to try to solve this complex problem, through legislation, policy changes, and other means, but the progress is slow, and slow is not good for a patient's health... Full

UnitedHealth's Unit to Launch New Drug Pricing Model Next Year

(5/20, Sriparna Roy, Reuters) ...UnitedHealth said on Monday its unit OptumRx would offer a new pricing model, starting next year, to help manage insurers' costs for drugs. The new model, Optum Rx Clear Trend Guarantee, will provide value-based pricing of drugs per member combining the cost of these medicines from various sources such as retail pharmacy, home delivery, specialty drug and rebates... Full

High Price of Popular Diabetes Drugs Deprives Low-Income People of Effective Treatment

(5/21, Renuka Rayasam, KFF Health News) ...Supply shortages and insurance hurdles for this powerful class of drugs, called GLP-1 agonists, have left many people who are suffering from diabetes and obesity without the medicines they need to stay healthy. One root of the problem is the very high prices set by drugmakers. About 54% of adults who had taken a GLP-1 drug, including those with insurance, said the cost was "difficult" to afford, according to KFF poll results released this month. But it is patients with the lowest disposable incomes who are being hit the hardest... Full

Expert Highlights The Role of Patient Support Programs, AI in Improving Access to Specialty Medications

(5/20, Pharmacy Times) ...Josh Marsh, vice president and general manager of Cardinal Health Sonexus Access and Patient Services, discusses the role of patient support programs and artificial intelligence in improving patient access to specialty medications. He outlines 3 main challenges patients face in gaining access to specialty medications - education, access, and affordability. The potential of AI to help pharmacists by automating administrative tasks and allowing them to focus more on clinical consultation with patients is discussed... Full

PBM Executives Invited to Testify Before House Panel

(5/20, Rachel Cohrs Zhang, STAT Plus) ...Executives from the three major pharmacy benefit manager companies have been invited to testify before the House Committee on Oversight and Accountability next month, four sources familiar with the planning told STAT. Executives from Optum, CVS Caremark, and Express Scripts, owned by Cigna, were asked to testify before the panel on June 4...Lawmakers are next eyeing action in December, when a number of health care programs and authorities are expiring. Ipsita Smolinski, founder and managing director of the consulting firm Capitol Street, said she believes some PBM reforms will pass in December, but not ones that are detrimental to the industry's business model... Sub. Req'd

US Pharma and Biotech Summit 2024: The 2024 Presidential Election and the Pharma Industry

(5/20, Don Tracy, PharmExec.com) ...In an interview with Pharm Exec Associate Editor Don Tracy, Robert Zirkelback, Chief Public Affairs Officer, Head of Strategic Initiatives, PhRMA discusses the upcoming United States presidential election and the potential impact that it could have on the pharma industry... Full

US Pharma and Biotech Summit 2024: Solving Drug Pricing

(5/21, Mike Hollan, PharmExec.com) ...Healthcare costs in the United States are a major issue for many families. At the 2024 US Pharma and Biotech Summit, Sarah Emond from the Institute for Clinical and Economic Review and John O'Brien from the National Pharmaceutical Council discussed the issue from a drug pricing perspective and how it might be solved. Both speakers agreed that it's an amazing moment in the pharma and biotech industry, from a science perspective... Full

Kimberly Westrich's ICER Recommendations to Improve Drug Pricing Data Accuracy

(5/20, Pearl Steinzor, AJMC) ...Kimberly Westrich, MA, chief strategy officer of the National Pharmaceutical Council, shares 3 key recommendations to improve the accuracy and quality of drug pricing data...The first one is methods, and there's all sorts of things that ICER could do to change their methods...Point number 2 is eliminating what ICER is calling it's shared savings model...The third area is patients themselves... Full

Industry Praises CMS For Punting ‘Stacking' Change For Medicaid Best Price

(5/20, Gabrielle Wanneh, InsideHealthPolicy) ...In a move applauded by the health care industry, CMS has decided to hold off finalizing a proposal that would have required drug makers aggregate, or "stack," all manufacturer price concessions to determine a final best price for a covered outpatient drug in Medicaid's Drug Rebate Program (MDRP), including discounts, rebates or other arrangements made to different best price-eligible entities throughout the drug supply chain, the agency said Friday (May 17) in an update on a proposed rule related to the MDRP... Sub. Req'd

Will Congress Finally Act on Patent Thickets?

(5/20, Alex Brill and Christy Robinson, Matrix Global Advisors) ...A bipartisan Senate effort to crack down on drug companies that game the patent system to shut out cheaper competitors has become a bargaining chip in the roiling debate over pharmaceutical prices. . . [W]hile the Senate Judiciary Committee advanced the bill this summer, it's being blocked by Democratic senators looking for assurances the chamber's GOP leaders will take up comprehensive legislation to address drug costs... Full

Senate's New Controversial Patent Reform Target

(5/20, Victoria Knight, Axios) ...Sens. Chris Coons and Thom Tillis are pushing a pair of bills that they say are essential to overhauling the patent process, including for drugs and genomics, but that critics contend could wind up helping the pharmaceutical industry...The bills, known as the PREVAIL and PERA acts, could see committee action relatively soon, Coons and Tillis told Axios last week...Both the PREVAIL and PERA Acts would alter the patent system as a whole but have a particular impact on the life sciences and drug development, said Chris Bruno of McDermott Will and Emery, who's represented pharmaceutical companies... Sub. Req'd

FTC Oversight of Pharmaceutical Sector 'Minimal' Over Last 20-Plus Years

(5/20, Shannon Firth, MedPage Today) ...The Federal Trade Commission pursued about one merger action and three enforcement actions per year in the pharmaceutical industry over the last two decades, accounting for only a sliver of the alleged misconduct in the sector, a study of publicly available documents showed...Of the 62 mergers the FTC challenged, 61 were given the greenlight after settlements, and one was abandoned. The 22 enforcement actions led primarily to settlements, as well as one FTC order and one judgment in the agency's favor, they noted in JAMA... Full

Maryland PDAB Gives Thumbs Up To Cost Reviews For Six Drugs

(5/20, Luke Zarzecki, InsideHealthPolicy) ...Maryland's prescription drug affordability board voted Monday (May 20) to move forward with cost review studies for six drugs, including the blockbuster drug for diabetes and obesity Ozempic. The drugs are AbbVie's Skyrizi, Eli Lilly's Trulicity, Novo Nordisk's Ozempic, Boehringer Ingelheim's Jardiance, AstraZeneca's and Bristol-Myers Squibb's Farxiga, and Sanofi's Dupixent, with the cost review of Dupixent scheduled to come after the others... Sub. Req'd

State Board Targets Six Prescription Drugs to Review for Affordability for Marylanders

(5/20, Danielle J. Brown, Maryland Matters) ...After the slow start, Monday's meeting marks the first time a handful of drugs will officially undergo "cost review," in which board staff will seek public comments, additional information and data over the next 60 days to determine if Marylanders struggle to afford treatments for diabetes, moderate-to-severe eczema and other diseases treated by the targeted medications. The board is still months away from potential cost-reduction efforts... Full

With Prescription Drug Bills, Vermont Lawmakers Hope to Lower Pharmaceutical Prices

(5/21, Peter D'Auria, VTDigger) ...As legislators scrambled to wrap up the legislative session earlier this month, they passed two bills that aim to reform how prescription drugs are priced and distributed...One of the bills, H.233, targets pharmacy benefit managers - aka PBMs - companies that administer prescription drug benefits for a health insurance company...The bill would also ban some PBM practices, such as spread pricing, a tactic in which a PBM charges a health insurer more for a drug than the PBM pays a pharmacy to dispense that drug... Full

Taking European Biosimilars To The Next Level

(5/20, David Wallace, Generics Bulletin) ...Speaking with Generics Bulletin on the sidelines of the conference, Isabell Remus, chair of Medicines for Europe's biosimilar medicines sector group and head of biopharma and specialty at Sandoz, and Julie Maréchal-Jamil, director of biosimilar policy and science at Medicines for Europe, discussed the key areas that industry and regulators need to focus on to best take advantage of the opportunities offered by biosimilars... Global Sub. Full

Eli Lilly's Diabetes Drug Tirzepatide Gets Approval in China

(5/21, Andrew Silver, Reuters) ...Eli Lilly said on Tuesday its diabetes drug tirzepatide has received approval from Chinese regulators, setting up intensifying competition with its Danish rival Novo Nordisk in the key Asian market...Eli Lilly did not say when sales would begin in China or how many doses would be supplied... Full

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