Thursday, April 18, 2024

Teva Says The Time Is Right For Two Big Immunology Biosimilar Launches

(4/17, Jessica Merrill, Scrip) ...[S]enior VP of US market access Tom Rainey said Teva is confident it is entering the adalimumab market at the right time, now that payers have had more than a year of experience with biosimilars, and that lessons learned with adalimumab will translate to Stelara. "I believe that the biosimilar market is kind of evolving right as we speak," Rainey said. "We're coming right in at the wave of the opportunity when things are changing."... Sub. Req’d

Alvotech Lauds Development, Manufacturing Platform As Ustekinumab Wins US Approval

(4/17, Dean Rudge, Generics Bulletin) ...Alongside the commercial power of its partner Teva, Alvotech expects to gain an edge from using an Sp2/0 host cell line for Selarsdi, allowing for more efficient sialyation of the molecule compared to Chinese hamster ovary cells, and a continuous perfusion process – "the same type of host cell line and process used in the production of Stelara."... Global Sub. Full

Stelara Biosimilar from Alvotech, Teva Approved by FDA

(4/18, BioPharma Dive) ...Selarsdi and Simlandi are the first two biosimilars to emerge from a strategic partnership between Alvotech and Teva originally inked in 2020 and expanded in 2023. Teva will be responsible for marketing Selarsdi in the US... Full

Drug Shortages at Highest Since 2014: Chemo Drugs, Wegovy, ADHD Medications Affected

(4/17, Anthony Robledo, USA Today) ..."All drug classes are vulnerable to shortages. Some of the most worrying shortages involve generic sterile injectable medications, including cancer chemotherapy drugs and emergency medications stored in hospital crash carts and procedural areas," ASHP CEO Paul Abramowitz said in a blog post Thursday. Abramowitz added that the scarcity of ADHD medications also pose a severe challenge for patients and clinicians... Full

Employers Battle with Drugmakers over Weight-Loss Drug Costs

(4/18, Kelly Hooper, Politico) ...What happened in North Carolina is playing out across the U.S. as large employers try to limit the costs of the expensive new generation of weight-loss drugs. And it is exposing how the U.S. drug pricing system, which gives manufacturers a lot of clout, can end up keeping patients from gaining access to highly effective treatments... Full

'Kids Need to Breathe Just Like Adults Do': $35 Price Caps Don't Apply to Asthma Meds Young Children Need, Doctors Say

(4/17, Meg Tirrell, CNN) ...Asthma drugs can be pricy across the board, so much so that the Senate health committee, led by Sen. Bernie Sanders, opened an investigation into the situation in January. Shortly afterward, three of the biggest makers of asthma inhalers, including GSK, pledged to cap out-of-pocket costs for some US patients at $35. The problem, doctors and parents told CNN, is those pledges don't apply to daily inhalers used by the youngest kids with asthma... Full

Taro Agrees $36m Securities Settlement Over US Price-Fixing Claims

(4/18, Dean Rudge, Generics Bulletin) ...Taro Pharmaceutical has asked a court in Manhattan to approve a $36m settlement to resolve a class action lawsuit claiming that the Sun Pharma subsidiary misled investors about its involvement in alleged generic price fixing for two years, to the detriment of the price of the company's securities... Global Sub. Full

Odd Lots: How The American Workforce Got Hooked on Adderall

(4/18, Bloomberg) ...Over the last few years, users of the popular ADHD drug Adderall have been frustrated by regular shortages in getting their prescriptions filled. Various regulatory and supply chain factors have contributed to the inability of producers to keep up with demand. But this raises the question: why is there so much demand in the first place?... Full

Organon And Henlius Complete Phase III For Denosumab

(4/18, David Wallace, Generics Bulletin) ...Organon and Shanghai Henlius Biotech will be looking to move ahead with filings for their HLX14 proposed biosimilar rival to Prolia/Xgeva (denosumab), after reporting that the candidate has met primary endpoints in a Phase III study... Global Sub. Full

Norwich Bruised As Failed US Rifaximin Appeal Bars Approval Until 2029

(4/17, Dean Rudge, Generics Bulletin) ...Norwich Pharmaceuticals looks set for a five-year wait to launch its generic version of Bausch Health's core Xifaxan, after the Federal Circuit shot down its appeal to a bar on US FDA approval. The generics manufacturer has previously sought to supercharge its approval by carving a patent-protected indication from the label... Global Sub. Full

Shilpa Medicare Announces Launch of PEMRYDI RTU

(4/17, Business Standard) ...Shilpa Medicare's marketing partner, Amneal Pharmaceuticals, has launched PEMRYDI RTU (Pemetrexed injection 10 mg/mL), the first ready-to-use pemetrexed formulation in the US market. The product has already been granted permanent J-code (J9324) by U.S. Centers for Medicare & Medicaid Services (CMS)... Full

AAN 2024: Amneal Showcases IPX203's Safety Profile in Anticipation of FDA Approval

(4/17, Clinical Trials Arena) ...At the American Academy of Neurology (AAN) 2024 Annual Meeting, Amneal Pharmaceuticals presented new safety data for IPX203 (carbidopa + levodopa, CD/LD) from its Phase III clinical trial RISE-PD and open-label extension in Parkinson's disease (PD) patients with motor fluctuations... Full

Despite Uptake Barriers, Real-World Biosimilar Data Demonstrate Safety, Efficacy, Cost-Effectiveness

(4/17, Kyle Munz, AJMC) ...Biosimilars were a recurring subject at the Academy of Managed Care Pharmacy (AMCP) 2024 annual meeting. On April 16, the first presentation exploring biosimilars reviewed the current landscape of these medications and their context in rheumatology, as well as showcased real-world efficacy and safety data and ongoing trends in this area... Full

Hospitals Slam HHS Drug Shortage Proposal For Overlooking GPOs

(4/17, Maaisha Osman, InsideHealthPolicy) ...The Association for Accessible Medicines (AAM), which lobbies for generic drug manufacturers, also tells Inside Health Policy while there is an assumption that incentivizing hospitals to alter their purchasing practices will influence GPOs to do the same, it is unclear whether this will in fact prompt such changes... Sub. Req’d

Democratic Senators Demand Answers on Novo Nordisk's Discontinued Insulin

(4/17, Joseph Choi, The Hill) ...The lawmakers requested details regarding the formulary placement of Levemir and what Congress could to alleviate any issues; information on the supply chain constrains that Novo Nordisk cited; and what steps the company is taking to ensure patients on Levemir have access to a similar product with similar cost-sharing... Full

Seniors Pay More for Generic Medicines Every Year While Prices Continue to Fall. Why?

(4/17, AAM) ...The Association for Accessible Medicines, the leading trade association for generic and biosimilar manufacturers, commented on an analysis released yesterday by Avalere showing that Medicare plans increase patient costs for generic medicines by moving those medicines to more expensive formulary tiers. In 2011, 73% of generic drugs analyzed by Avalere were placed on Tier 1, which has a zero-dollar copay on average. Ten years later, only 15% of those drugs were still on Tier 1, despite the average price of those medicines falling by 38% between 2011 and 2019... Full

Are Your Prescription Drugs Affordable? Colorado Board Wants Feedback on These 2

(4/17, Lanie Lee Cook, KDVR) ...Cosentyx, which treats psoriasis, and Stelara, for Crohn's disease, are now under the microscope of the Prescription Drug Affordability Board... Full

Colorado Pharmacies Concerned Over PDAB UPL Reimbursements

(4/17, Luke Zarzecki, InsideHealthPolicy) ...Colorado pharmacies are concerned they may not receive adequate reimbursement after the state's prescription drug affordability board (PDAB) determines an upper payment limit (UPL) for drugs it deems unaffordable, and a pharmacy group says it has unanswered questions about the process... Sub. Req’d

It's Not Just Congress. There's Plenty of State-Level Action on PBMs, Drug Costs and Prices | AMCP 2024

(4/17, Peter Wehrwein, Managed Healthcare Executive) ...Although the spotlight has shifted to Congress and legislation it might pass concerning pharmacy benefit managers (PBMs), state legislatures and healthcare regulators are also enacting new laws and issuing new rules affecting the industry. Adam Colborn, director, government affairs, of Academy of Managed Care Pharmacy (AMCP) discussed state-level developments today at presentation at AMCP's annual meeting in New Orleans... Full

Julie Reed: Why 2024 Is Important for Biosimilars

(4/17, Skylar Jeremias, The Center for Biosimilars) ...Between 10 newly launched adalimumab biosimilars, hope for pharmacy benefit manager (PBM) reform, and the implementation of drug price negotiations under the Inflation Reduction Act (IRA), 2024 is shaping up to be another big year for biosimilars, according to Julie Reed, executive director of the Biosimilars Forum... Full

FDA-EMA Advice Pilot For Complex Generics: What Does Industry Have To Say?

(4/17, Urte Fultinaviciute, In Vivo) ...However, complex generics, or hybrid medicines in Europe, had not been part of the transatlantic discussion, said Beata Stepniewska, head of regulatory affairs at off-patent association Medicines for Europe. She told In Vivo that the complex generics sector was "a bit of an empty space" and the industry needed a platform to have harmonization or convergence discussions... Full

IGBA Comments on Selected Provisions of The March 13, 2024 Proposal for Negotiating Text of The WHO Pandemic Agreement

(4/17, IGBA) ...As the international representative organization of the generic and biosimilar medicines industry, IGBA joins the WHO and Member States in reaffirming the importance of multisectoral collaboration to safeguard human health and build stronger, more resilient health systems... Full

Shortages of Life Saving Medicines Has Become ‘New Normal' for UK After Brexit

(4/18, Rebecca Thomas, Storm Newton, The Independent) ...Shortages of life-saving medication such as antibiotics, epilepsy and cancer drugs compounded by Brexit have worsened the UK's " broken" supply chain, researchers have warned...Experts at the Nuffield Trust think tank described the problem as a "shocking development" that puts pressure on patients, GPs and pharmacists. Their warnings come following reports of the scarcity of vital chemotherapy drugs, such ascisplatin and carboplatin,and medicine for ADHD... Full

Denmark Planning To Impose Drug Stockpiling Obligations From July

(4/17, Ian Schofield, Pink Sheet) ...The measures, intended to tackle the problem of drug shortages, are contained in a bill that was put out for consultation by the Ministry of the Interior and Health in February with a deadline for comments of 22 March. If the new rules are approved, "patients will be less affected by supply difficulties than today," the DKMA said... Sub. Req’d

Patient Information Leaflets: Putting Patients First

(4/17, Medicines for Europe) ...The European pharmaceutical industry, represented by AESGP, EFPIA, and Medicines for Europe, has joined forces to enhance the content of medicinal product information leaflets, prioritising patients' needs. These associations have put together key recommendations to improve leaflet content and accessibility, thus advancing health literacy... Full

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