Monday, April 22, 2024

Alvotech Moves to Bring its Humira Biosimilar to US Market

(4/19, Justine Ra, Pharmaceutical Technology) ...Alvotech did not name the stratetic partner in its 19 April press release. The agreement, which was signed under consensus with Teva, will not alter the multi-product commercialisation partnership between the two companies, with Teva continuing the commercialisation of Simlandi in the US... Full

Alvotech Deal Could Heighten Biosimilar Pressure on Humira

(4/19, Jennifer Gardner, BioPharma Dive) ...The deal comes seven weeks after the Food and Drug Administration approved Alvotech's biosimilar, Simlandi, which the agency previously rejected multiple times. For patients to receive treatment, Alvotech and Teva must first cut deals with drug wholesalers, pharmacies and insurers that negotiate prices before agreeing to cover the therapy... Full

Adderall Abuse Risks Becoming Another Opioid Crisis, DEA Says

(4/19, Ike Swetlitz, Bloomberg) ...The fast rise of prescriptions for Adderall and other stimulants, along with rampant online treatment and advertising, suggest the start of another drug crisis like the opioid epidemic, a senior Drug Enforcement Administration official said Thursday..."I'm not trying to be a doomsday-er here," said Matthew Strait, deputy assistant administrator in the diversion control division said in an online seminar. But he compared the current situation with stimulants to the beginning of the opioid crisis and said "it makes me feel like we're at the precipice of our next drug crisis in the United States."... Sub. Req’d

Lupin Launches Generic Drug in US Market

(4/22, Money Control) ...Drug maker Lupin on Monday said it has launched Mirabegron extended-release tablets (25 mg) in the US market...The company's product is a generic equivalent of Astellas Pharma Global Development, Inc's Myrbetriq extended-release tablets, it added... Full

Zydus Lifesciences Launches Generic Drug for Overactive Bladder in US Market

(4/22, PTI) ...The company has launched Mirabegron extended-release tablets in strength of 25 mg in the US market after having received final approval from the US Food and Drug Administration (USFDA), Zydus Lifesciences said in a regulatory filing. Zydus is among the first suppliers to launch the generic version of Mirabegron extended-release tablets (USP 25 mg) in the US market... Full

Nora Pharma Receives Health Canada Approval for Niopeg®, a Biosimilar of Neulasta®

(4/19, Nora Pharma) ...Nora Pharma, a wholly owned division of Sunshine Biopharma, has received approval from Health Canada for the commercialization of NIOPEG® (a pegylated form of filgrastim) in Canada... Full

Patient Perceptions of Switching From the Reference Adalimumab to Amjevita During its Initial Launch

(4/20, Deana Ferreri, PhD, The Center for Biosimilars) ...In a survey of patients with autoimmune arthritis who had been switched from reference adalimumab (Humira) to biosimilar adalimumab-atto (Amjevita; Amgen), 63% either preferred the biosimilar or had no preference for either, 87% had no concerns about losing disease control due to switching, and 49% reported adequate knowledge about the safety and efficacy of the biosimilar. The authors called for future research to "assess means to educate effectively patients on biosimilars' safety and efficacy."... Full

Biden Sees a $35 Price Cap for Insulin as a Pivotal Campaign Issue. It's Not That Clear-Cut

(4/21, Will Weissert, Associated Press) ...Many who are benefiting from the price cap were already getting insulin at reduced prices, were already Biden supporters, or both. Others who need reduced-price insulin, meanwhile, cannot get it because they do not have Medicare or private health insurance... Full

Biosimilars Council Calls Out PBMs For Suppressing Humira Biosimilars Adoption

(4/22, Adam Zamecnik, Generics Bulletin) ...According to the new analysis cited by the Biosimilars Council, the slow rollout of Humira biosimilars is partly caused by the adoption of suppressive strategies by pharmacy benefit managers, who act as administrative intermediaries behind prescription drug programs... Sub. Req’d

ASHP Warns States Must Align Laws With New Part D Biosimilars Policy

(4/19, Inside Health Policy) ...The pharmacist lobby is planning to form model legislative language that states could use to authorize pharmacists to switch any kind of biosimilar into a formulary for its reference product, not just interchangeable biosimilars, and to do so without having to wait for a patient to speak with their prescribing provider... Sub. Req’d

Califf Talks Bolstering Domestic Drug Manufacturing, Foreign Inspections at House Hearing

(4/19, Lia DeGroot, Endpoints News) ...Appearing before a House Appropriations panel to defend the agency's budget request for fiscal year 2025, representatives peppered Califf with questions about how the FDA can play a role in reshoring overseas generic drug manufacturing to the US. He also told the panel that while challenging, the FDA has made some progress in conducting more unannounced inspections overseas...Califf told lawmakers that the FDA has conducted 100 unannounced inspections in India and is up to the "double digits" in China... Sub. Req’d

Partisan Politics Returns To US FDA Congressional Oversight

(4/19, Michael McCaughan, Pink Sheet) ...There were some moments of bipartisan agreement, at least in the sense that Califf heard similar messages from at least one member of each party. For example, Reps. Ro Khanna, D-CA, and Nick Langworthy, R-NY, both pressed the commissioner to act more assertively in addressing what they see as brand name patent abuses... Sub. Req’d

GOP Reluctant To Raise FDA Budget As Stakeholders Lobby For Big Increase

(4/19, Jessica Karins, InsideHealthPolicy) ...In its official funding request for fiscal 2025, the Alliance for a Stronger FDA says FDA should receive budget authority appropriations of $3.896 billion for salaries and expenses, plus $19 million for buildings and facilities. The number is the amount the Biden administration proposed for the agency in its fiscal 2024 budget, but the president's fiscal 2025 request is substantially lower... Sub. Req’d

FDA Official: Biowaiver Framework Needed for Modified Release Generics

(4/19, Joanne S. Eglovitch, Regulatory Focus) ...There is a need for the scientific community to explore the use of additional strength biowaivers for modified release (MR) drugs given the increasing market demand for these "patient centric" products, said Robert Lionberger, director of the US Food and Drug Administration's (FDA) Office of Research and Standards in the Office of Generic Drugs. Lionberger made these remarks at the 18 April FDA/PQRI workshop on challenges and opportunities for modified release oral drug product development... Full

Drug Shortages Threaten Patients: How Pharma Can Build Supply Chain Resilience

(4/19, Charles Sternberg, Contract Pharma) ...Strategies may encompass supply chain optimization, the adoption of cutting-edge technologies, or diversification of sourcing channels. Improving market forecasts also emerges as a pivotal factor in averting drug shortages. Accurate demand prediction facilitates precise production and distribution planning, reducing the likelihood of supply chain disruptions... Full

Drug Shortages Plague Patients. There's a Solution

(4/21, Henry Miller, Washington Examiner) ...To ameliorate drug shortages, we need a policy change that would enable overseas manufacturers to sell products in the United States that already have received marketing approval from certain foreign governments with standards comparable to those of the Food and Drug Administration, and vice versa. In a word: reciprocity... Full

DoP Study Asks Indian Companies to Address Challenges to Grab $251 Billion Opportunities from Patent Cliff

(4/22, Gireesh Babu, Pharmabiz) ...With over 20 drugs with sales worth $251 billion are going off-patent in the current decade, the Indian pharma industry need to address several challenges including the complex intellectual property (IP) landscape, lack of research and development (R&D) and innovation, regulatory compliance, among others in order to grab the opportunity, says a study conducted by the Department of Pharmaceuticals... Full

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