Monday, February 26, 2024

Teva, Jiangsu Nhwa Pharmaceutical Enter Partnership

(2/26, The Fly) ...Teva Pharmaceutical Investments Singapore, or TPIS, a subsidiary of Teva, and Jiangsu Nhwa Pharmaceutical announced it formed a partnership for the marketing and distribution of Teva's Austedo for the treatment of neurodegenerative and movement disorders - chorea associated with Huntington's disease, or HD, and tardive dyskinesia, or TD, in adults... Full

Teva and Jiangsu Announce Partnership for Distribution of AUSTEDO in China

(2/26, Nilanjana Basu, Seeking Alpha) ...Teva Pharmaceutical Investments Singapore, unit of Teva Pharmaceutical and Jiangsu Nhwa Pharmaceutical announced a partnership for the marketing and distribution of Teva's AUSTEDO (deutetrabenazine)...The partnership intends to increase patients' access to Teva's AUSTEDO... Full

After Long Road to Approval, Teva and Alvotech Believe Their Humira Biosimilar Simlandi May Have An Edge

(2/23, Fraiser Kansteiner, Fierce Pharma) ...Teva and Alvotech have braved a long and winding road on the quest to win approval for their biosimilar to AbbVie's Humira. Now, after multiple manufacturing setbacks, the partners have finally scored their inaugural regulatory nod in the United States. Late Friday, the U.S. FDA approved the two companies' Simlandi as the first citrate-free, high-concentration biosimilar to Humira with a coveted interchangeability tag... Full

Teva Has Sights On $12.2 Billion Humira Market After Receiving FDA Approval For Arthritis Injection

(2/25, Meir Orbach, CTech) ..."The approval of SIMLANDI marks the first high-concentration, citrate-free biosimilar to Humira with IC status," said Dr. Eric Hughes, Executive Vice President Global R&D and Chief Medical Officer at Teva. "Biosimilars create opportunities for cost savings across the healthcare system and introduce additional treatment options for patients. This approval marks an important milestone for Teva and Alvotech's partnership to collaborate on seven biosimilars and expand the availability, access, and uptake of biosimilars in the U.S."... Full

Teva and Alvotech's Interchangeable Humira Biosimilar Joins The Party

(2/26, Nicole DeFeudis, Endpoints News) ...The partners will launch their interchangeable, high-concentration Simlandi "imminently," they said in a news release. The drug will be up against several other biosimilars already on the market, but Teva's CEO Richard Francis isn't worried about being late to the party. "I think there's obviously a lot to play for there still because 2023 was a slope with regard to penetration of the biosimilars," Francis said on the company's recent fourth-quarter earnings call, according to an AlphaSense transcript... Full

Alvotech FDA Approval Clears Path To Challenge Humira

(2/25, David Wallace, Generics Bulletin) ...It's been a long time coming, but Alvotech has finally snagged US Food and Drug Administration approval for its Teva-partnered US biosimilar rival to Humira (adalimumab). And despite coming to the market later than their peers, the firms believe that the unique attributes of Simlandi (adalimumab-ryvk) – which has been approved as the first citrate-free, high-concentration biosimilar to be designated interchangeable to Humira – will position them to robustly challenge AbbVie's brand as well as the other biosimilars already in the market... Global Sub. Full

Alvotech, Teva End Rough Road for Humira Biosimilar With FDA Approval

(2/26, Tristan Manalac, BioSpace) ...The FDA on Friday approved Alvotech and Teva's Simlandi (adalimumab-ryvk), a biosimilar to AbbVie's blockbuster antibody therapy Humira (adalimumab), ending a long and difficult regulatory road for the partners...Following the approval, Alvotech and Teva are working to launch Simlandi in the U.S. "imminently" with its interchangeability designation, the companies said... Full

FDA Approves Tenth Adalimumab Biosimilar, Simlandi

(2/24, Skylar Jeremias, The Center For Biosimilars) ...Alvotech has had to deal with significant challenges to get approval for its biosimilar portfolio, including receiving 3 CRLs regarding its Iceland-based manufacturing facility, of which 2 were for AVT02 and 1 was for AVT04 (ustekinumab biosimilar). The FDA has never found any issues with the biosimilar candidates themselves or Alvotech's data package. The US commercialization and marketing of the product will be conducted by Teva Pharmaceuticals as part of an exclusive partnership. Teva Pharmaceuticals also recently rejoined the Biosimilars Forum as an official member... Full

Interchangeable High-Concentration Humira Approved in US

(2/26, Phil Taylor, Pharma Phorum) ...The formulation accounts for around 88% of prescriptions of the immunology drug, according to sales data from Symphony cited by Teva, which said it will launch the new biosimilar "imminently." Teva and Alvotech reckon that interchangeability will unlock growth in the market for biosimilar Humira, which has developed relatively slowly, despite the approvals of several products in the 12 months or so since the blockbuster brand lost market exclusivity last year... Full

FDA Approves Alvotech and Teva's Simlandi as Interchangeable Humira Biosimilar

(2/26, Emily Kimber, PMLive) ...The US Food and Drug Administration has approved Alvotech and Teva's Simlandi (adalimumab-ryvk) injection as an interchangeable biosimilar to AbbVie's Humira (adalimumab)...The drugs have no clinically significant differences in terms of safety or effectiveness from the reference product, but they potentially lower healthcare costs... Full

FDA Approves Simlandi, Third Interchangeable Humira Biosimilar

(2/24, Peter Wehrwein, Managed Healthcare Executive) ...Alvotech and Teva Pharmaceuticals announced the FDA approval in a news release issued last night at 8:15 p.m. EST. Teva, a major generic medication manufacturer and marketer, will commercialize and market Simlandi in the U.S. European drug regulators approved the biosimilar in 2021 and it is marketed in Europe under a different name, Hukyndra. The news release touts as the Simlandi as the first high-concentration, citrate-free biosimilar to Humira that is interchangeable... Full

Alvotech/Teva Win FDA Approval for Humira Biosimilar

(2/26, Preeti Singh, Seeking Alpha) ...Alvotech and partner Teva Pharmaceuticals announced Friday the U.S. Food and Drug Administration approval for their arthritis injection, Simlandi (adalimumab-ryvk)...Teva serves as Alvotech's strategic partner for the exclusive commercialization of Simlandi in the U.S. as part of a 2020 agreement. Simlandi marks the first biosimilar approval under the strategic partnership. The injection is expected to roll out in the U.S. soon with interchangeability designation... Full

FDA Approves Simlandi As First High-Concentration Interchangeable Biosimilar to Humira

(2/26, The Pharma Letter) ...Icelandic firm Alvotech and Israel's Teva Pharmaceutical Industries on Friday announced that the US Food and Drug Administration has approved Simlandi (adalimumab-ryvk) injection...Shares of Alvotech gained almost 3% to $16.03 on the news, while those of Teva rose 4% to 4,974 shekels but fell 1.2% to $12.89 in New York trading... Sub. Req'd

FDA Approves Alvotech-Teva's SIMLANDI Jab for Multiple Conditions

(2/26, Pharmaceutical Technology) ...The US Food and Drug Administration has granted approval for Alvotech and Teva Pharmaceuticals' SIMLANDI (adalimumab-ryvk) injection, an interchangeable biosimilar to Humira, for a range of conditions...Alvotech's partner, Teva, will exclusively market the biosimilar in the US, leveraging its sales and marketing infrastructure. SIMLANDI's distinction lies in its high-concentration formulation, which aligns with the preference of approximately 88% of US adalimumab prescriptions... Full

Alvotech Shares Rise Premarket After Humira Biosimilar Approval

(2/26, Colin Kellaher, Dow Jones) ...Shares of Alvotech rose sharply in premarket trading after the biotechnology company won a key U.S. regulatory approval for its biosimilar to the blockbuster anti-inflammatory drug Humira and agreed to raise $166 million in a stock sale. Alvotech and partner Teva Pharmaceuticals late Friday said the U.S. Food and Drug Administration approved its Simlandi injection as an interchangeable biosimilar to AbbVie's 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... Sub. Req'd

In Washington, The Answer Is Drug Shortages But What Is The Question?

(2/23, Bowman Cox, Pink Sheet) ...Rep. Jamie Raskin, D-MD, ranking member of the House Committee on Oversight and Accountability, and 14 Democratic committee colleagues have penned letters to Teva Pharmaceuticals USA Inc. about the shortage of Adderall and its generic equivalents, to Pfizer Inc. about the cancer drug shortages, and to Sandoz Inc. about the antibiotics shortages. "Our constituents share story after story detailing how hard it is to fill prescriptions for Adderall and that the shortage affects every element of their lives," the Teva letter said. Although prescription stimulant shortages are often attributed to a failure of Drug Enforcement Administration allotments to keep up with rising demand, the letter to Teva asked questions about the firm's failure to consistently produce its full allotment... Sub. Req'd

TL1A Inhibitors Could Usher in New Era for IBD Treatment

(2/23, Jill Neimark, BioSpace) ...Twenty-two years ago, a molecule called TL1A was first discovered and isolated. Today, after two decades of research, therapeutics to calm its activity may usher in a new era for the treatment of immune-mediated diseases like inflammatory bowel disease, psoriasis and rheumatoid arthritis...In June, Merck completed the purchase of Prometheus Biosciences for $10.8 billion...Then in October, Roche paid $7.1 billion for Roivant subsidiary Televant Holdings and its anti-TL1A antibody RVT-3101, also for IBD. That same month, Sanofi and Teva Pharmaceuticals announced a collaboration worth a potential $1.5 billion to co-develop TEV-'574, a TL1A inhibitor currently in Phase IIb clinical trials for IBD... Full

AbbVie's Humira Is a Textbook Case for Drugmakers Navigating Patent Cliff

(2/23, Greg Slabodkin, BioSpace) ...The AbbVie business model may have ripped off patients in this country, forcing them to pay inflated prices for their prescriptions, but it made Humira into one of the highest-grossing drugs of all time by preserving the company's pricing power and bringing in more than $200 billion in revenue during its lifetime...At the same time, other drugmakers have successfully implemented similar strategies for some of their top-selling drugs, including Bristol Myers Squibb's Eliquis, Johnson & Johnson's Stelara and Merck's Keytruda—all of which are set to lose exclusivity over the next few years... Full

Samsung Bioepis And Sandoz Get EU Nod For Stelara Rival

(2/23, David Wallace, Generics Bulletin) ...Samsung Bioepis has become the latest firm to win a European Medicines Agency endorsement for an ustekinumab biosimilar, after the firm's SB17 proposed rival to Stelara won a positive opinion from the agency's Committee for Medicinal Products for Human Use...At the same time as the ustekinumab biosimilar positive opinion was issued, the CHMP also endorsed two generics for Accord Healthcare... Global Sub. Full

Celltrion, Samsung Bioepis Unveil New Biosimilar Data in CD, UC at ECCO 2024

(2/23, Skylar Jeremias, The Center For Biosimilars) ...At the Congress of European Crohn's and Colitis Organisation, Celltrion and Samsung Bioepis presented new finding from their respective biosimilar analyses, demonstrating positive safety and efficacy measures for the biosimilars as treatments for Crohn disease and ulcerative colitis... Full

Leaner Kabi Drives Higher Savings Goal For Fresenius, China ‘Soft' In 2024

(2/23, Dean Rudge, Generics Bulletin) ...Fresenius Kabi insists there is a "business plan behind everything" as it divulged a higher cost savings goal for the end of next year, following a fruitful 2023. But queries over margins led the company to stress that it was combatting a variety of uncertainties, especially in China and for its burgeoning biosimilars unit... Global Sub. Full

EPIC Epinephrine Patent Lawsuit Against BPI Labs Moves Forward

(2/23, James Arkin, Bloomberg Law) ...Belcher Pharmaceuticals LLC must face Endo Par Innovation Co. LLC's lawsuit accusing it of copying a patent-protected formula for stable injectable epinephrine, a life-saving medication for people suffering severe allergic reactions. Judge William F. Jung of the US District Court for the Middle District of Florida denied Belcher and BPI Labs LLC's motion to dismiss the lawsuit in a Thursday opinion... Sub. Req'd

Sun Pharma, Lupin, Alkem Recall Products from US Market

(2/25, Neethi Rojan, Money Control) ...Pharmaceutical products manufactured by Sun Pharma, Lupin Laboratories and Alkem Laboratories are being recalled from the US market, as per a list issued in the weekly enforcement report of the US Food and Drug Administration...All three recalls were Class II recalls according to the USFDA. A Class II recall is where the use of, or exposure to the product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote, according to the US FDA... Full

Antidepressant Prescriptions to Youths Spiked During and After the Pandemic, Study Finds

(2/26, Kristen Rogers, CNN) ...Many young people have reported having poor mental health during and after the Covid-19 pandemic. Their experiences are affirmed by a new study finding that the rate of prescribing antidepressants to this group also spiked during the same period. The number of young people between the ages 12 and 25 receiving antidepressants was already growing before the pandemic. But since the Covid-19 outbreak in the United States in March 2020, the dispensing rate rose nearly 64% faster than normal, according to the study published Monday in the journal Pediatrics... Full

Potential Urology Drug Savings Through Mark Cuban Drug Company

(2/23, Hannah Clarke, Managed Healthcare Executive) ...A recent study published in Urology Practice suggests that the Mark Cuban Cost Plus Drug Company may offer patients cost savings on commonly prescribed urologic medications...According to the authors of the current study, past research on the online pharmacy has focused on possible savings if Medicare were to purchase drugs at MCCPDC pricing. The current study aimed to assess the possible cost savings for patients with the MCCPDC compared with other mail-order pharmacies, local pharmacies, and health insurance... Full

UnitedHealth Subsidiary Change Healthcare Down for a Fourth Day Following Cyberattack

(2/24, Ashley Capoot, CNBC) ...Change Healthcare's systems are down for a fourth straight day after parent company UnitedHealth Group disclosed that a suspected cybersecurity threat actor gained access to part of its information technology network on Wednesday...CVS Health is continuing to fill prescriptions, but it is not able to process insurance claims in certain cases, the company told CNBC in a statement on Saturday. CVS Health said there is "no indication" that its own systems have been compromised... Full

Bipartisan Group of Lawmakers Opposes Biden's Plan to Use 'March-In' to Lower Drug Prices

(2/23, Zachary Brennan, Endpoints News) ...A group of 28 senators and members of Congress, including nine Democrats, sent a letter to President Joe Biden on Wednesday decrying his administration's recent proposal to exercise its so-called march-in rights when drug prices rise too high...Testifying at a public meeting at the NIH, the late Sen. Birch Bayh explained how proponents of using march-in rights to control prices "had misinterpreted the law's legislative history and that Congress would have to amend the law to allow ‘reasonable price' to be a factor in triggering march-in rights," the lawmakers note... Full

Congressional Efforts to Lower Drug Costs Keep Falling Short. Here's Why

(2/25, Sandip Shah and Krunal Patel, USA Today) ...The Inflation Reduction Act unintentionally discourages biotech firms from investing the time and money necessary to develop biosimilars. Here's why. The IRA permits Medicare officials to impose price controls on certain brand-name drugs, including many biologics. But the government does not have to reveal which medicines will be subject to price caps until just two years prior to the lower prices taking effect. As a result, a firm could hypothetically spend nearly a decade and hundreds of millions of dollars developing a biosimilar — only to find out that the original brand-name biologic will suddenly be much cheaper, courtesy of government price controls... Full

Part 3: Dr James Robinson On the Impact of 340B Programs and Drug Pricing Policies

(2/23, Maggie L. Shaw and Mary Caffrey, AJMC) ...In part 3 of our interview with James Robinson, PhD, MPH, he discusses the need for reforms to commercial insurance that reflect the changes to Medicare under the Inflation Reduction Act, how the 340B drug pricing program has veered widely from its original goals, and ongoing cost sharing struggles among patients, insurers, hospitals, and drug companies... Full

New York Attorney General Urges Stronger Safety Warning On Asthma Drug Singulair

(2/23, Robin Respaut and Dan Levine, Reuters) ...The attorney general for one of the most populous U.S. states this week urged federal drug regulators to address safety risks associated with the widely used asthma and allergy medicine Singulair, saying current warnings on the drug's packaging are insufficient, particularly for children...The letter cited a report from Reuters last year that found the FDA had received thousands of reports of patients, including many children, experiencing depression, suicidal thoughts and behaviors, or other psychiatric problems after taking Singulair or generic montelukast, since the drug was launched by Merck over 25 years ago... Full

Lilly's ‘High Quality' Donanemab Data Supports Unrestricted Medicare Coverage, Firm Says

(2/23, Cathy Kelly, Pink Sheet) ...The Centers for Medicare and Medicaid Services should reopen its Medicare national coverage determination for Eli Lilly and Company's Alzheimer's drug donanemab based on the company's clinical trial and real-world data, Lilly researchers conclude in a paper published in the journal Alzheimer's & Dementia earlier this month... Sub. Req'd

FDA Knows Its Own Strength—and It Includes Concentration

(2/26, Sara W. Koblitz & Kurt R. Karst, FDA Law Blog) ...Boehringer Ingelheim submitted a Citizen Petition in December 2020 encouraging FDA to interpret the term "strength" under the BPCIA differently than the Agency does under the Hatch-Waxman Act. Specifically, Boehringer asked FDA to interpret "strength" for biosimilars to mean "total drug content" to the exclusion of "concentration."... Full

Colorado PDAB First In Nation To Consider UPL For A Drug

(2/23, Luke Zarzecki, InsideHealthPolicy) ...An Amgen spokesperson told Inside Health Policy the company is weighing its options. "Amgen has significant concerns about the Colorado Prescription Affordability Board's actions including its inconsistent application of process and policies through the review period. Amgen is currently evaluating options available to it, including obtaining additional information as the upper payment limit rulemaking process proceeds,"Kelley Davenport, director of Amgen's global policy communications, said... Sub. Req'd

Oregon Suspends a Portion of its Drug Transparency Law Found to be Unconstitutional

(2/23, Ed Silverman, STAT Plus) ...In a victory for the pharmaceutical industry, Oregon officials have suspended a portion of a contentious state law designed to bring more transparency to prescription drug pricing. For now, the Oregon Department of Consumer and Business Services will no longer require drug companies to compile annual reports on price increases, a key feature of a transparency law that was enacted in 2018... Sub. Req'd

Taking Our Meds? Florida Sought FDA Approval to Import Canadian Drugs. Could It Lead to Shortages?

(2/25, Patty Winsa, The Toronto Star) ..."This is not sustainable," said Marc-André Gagnon, a professor at Carleton University who focuses on social, health and pharmaceutical policy. "We're talking about official drug programs for different states being able to buy their drugs through the Canadian pricing systems, with the approval of the drug company," said Gagnon. "So it's not really the development of good capacity. It's just theatre ... to show that (U.S. politicians) are trying to do something about this issue. "What you need (in the U.S.) is a system that regulates drug prices," said Gagnon... Sub. Req'd

Europa Perspectives: Helping to Navigate the Regualtory System

(2/23, Chris Spivey, PharmTech.com) ...Steffen Thirstrup, MD, PhD, chief medical officer, European Medicines Agency, was interviewed on Jan. 25, 2024 by Chris Spivey, editorial director of Pharmaceutical Technology® and BioPharm International® for the Europa Perspectives series...This segment of discussion pivots around manufacturing supply, drug shortages, commercial incentives, politics, and, ultimately, patient wellbeing. A less well-understood role of the EMA is how the agency's activities intersect with the factors driving pharmaceutical science forward... Full

EFTA Pursues Swift Trade Agreement With India Amid Concerns Over Drug Access Clause

(2/26, The Pharm Letter) ...The European Free Trade Association aims to conclude a trade agreement with India "within weeks," with the four-nation bloc showing a steadfast commitment to seal the deal before the Asian country enters its election cycle. However, concerns persist over a clause that may delay access to generic drugs in India for up to six years... Sub. Req'd

Health Canada Disclosing More Information On Pending Generic Drug Submissions

(2/25, Sarah Pennington, Paul Jorgensen and Kristin Wall, LexBlog) ...On February 23, 2024, Health Canada published a Notice advising that it was making its review process for generic drug submissions more transparent. Specifically, for generic drug submissions accepted into review on or after April 1, 2024, Health Canada will start disclosing: (i) the year and month that the submission was accepted for review; and (ii) the company sponsoring the generic drug... Full

Real-World Evidence Enters the Discussion for Biosimilar Switching

(2/23, Sara Miller, PharmD, Pharmacy Times) ...Pressure on drug markets across the globe is rising as the established cost savings of biosimilars remains an opportunity with unmet potential. Despite clear, defined criteria that ensure biosimilars have comparable safety and efficacy as the reference biologic, skepticism persists among prescribers. To combat soaring pharmaceutical costs, Health Canada is completing a nationwide mandatory biosimilar switch policy. Most provinces have adopted the policy, deeming this a critical time for prescriber biosimilar literacy and patient advocacy... Full

Israel's 2024 Health Basket Gets 110 New Medications and Technologies

(2/23, Renee Ghert-Zand, The Times Of Israel) ...This year will see an expansion of genetic testing, treatment for adult ADHD, innovative diabetes management, and new drugs for cancer and chronic and rare diseases. A committee appointed to expand Israel's national health basket for 2024 submitted its recommendations to Health Minister Uriel Buso on Thursday... Full

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