Thursday, October 24, 2024

FDA and Industry Experts Unpack Biosimilar Device Requirements

(10/23, Skylar Jeremias, The Center For Biosimilars) ...Moderator Maria Burkholder, MHA, senior director, regulatory affairs global biosimilars, Teva Pharmaceuticals, began the discussion by defining similarity and interchangeability in the context of generic applications and biosimilars. She explained the distinction between interchangeable and noninterchangeable biosimilars and presented a diagram illustrating the requirements for both to receive approval. The importance of use-related risk analysis and threshold analysis in biosimilar development was emphasized... Full

Teva v. Amneal -- Amneal's Responsive Brief & Teva's Reply Brief

(10/23, Kevin E. Noonan, Patent Docs) ...The Federal Circuit has been petitioned by plaintiff Teva Branded Pharmaceutical Products R&D, Inc. to reverse a decision in favor of Defendant Amneal Pharmaceuticals wherein the District Court entered an injunction ordering Teva to delist five Orange Book-listed patents, in Teva Pharms. Inc. v. Amneal Pharms. LLC. This post concerns Teva's Reply brief answering Amneal's Responsive brief to Teva's Opening Brief on appeal... Full

Amgen Will Launch First US Eylea Biosimilar At Risk

(10/23, Dean Rudge, Generics Bulletin) ...The first US biosimilar to Regeneron's Eylea (aflibercept) 2mg is imminent, after biosimilar sponsor Amgen obtained another favorable court decision...In the wake of the Federal Circuit's decision, an Amgen spokesperson confirmed to Generics Bulletin that the company was launching Pavblu. "We look forward to bringing Pavblu to patients as quickly as possible to help expand access to affordable and effective treatment," Amgen commented... Global Sub. Full

Despite Landing Biggest PBM Formularies, Celltrion's Zymfentra Not Listed By US Insurers

(10/23, Urte Fultinaviciute, Generics Bulletin) ...Celltrion gave updates on several business aspects and reassured its shareholders that the delayed insurance listing for Zymfentra will not affect its set annual sales goal. Getting on the three biggest pharmacy benefit managers' formulary lists in the US within half a year of a product launch is a big achievement, but even then, it is not guaranteed that the insurers under the PBMs will list it. This was the case for Celltrion... Global Sub. Full

ASHP Report: Drug Shortages On The Decline, But Issues Remain

(10/23, Luke Zarzecki, InsideHealthPolicy) ...The report, published Wednesday (Oct. 23), also found 60% of shortages were either reported by manufacturers as having an unknown cause or a cause was not provided. Active drug shortages are down from 323 in the first quarter of 2024, which ASHP recorded as the highest level in the past ten years. In the second quarter, the number of active drug shortages was 300. "Basic and life-saving products such as Rho(D) immune globulin, pain and sedation medications, and ADHD medications continue to be problematic," the report says... Sub. Req’d

Diabetes Patients Worry About Insulin Shortages as Ozempic Use Skyrockets

(10/24, Ken Alltucker, USA Today) ...George Huntley, the CEO of the Diabetes Leadership Council and an affiliate at the Diabetes Patient Advocacy Coalition, said the diabetes community worries about the insulin supply after periodic supply chain disruptions in the past year... Full

Samsung Bioepis Eyes Record Sales in 2024 After Stellar Q3

(10/24, Dae-Kyu Ahn, The Korea Economic Daily) ...The South Korean biosimilar-developing company under Samsung Group reported on Wednesday that its operating profit for the third quarter ended in September jumped 38% from the same period of last year to reach 67.9 billion won...Samsung Bioepis attributed the stellar results largely to milestone payments worth 220.5 billion won from its US and European partners Biogen Inc. and Sandoz Group AG, respectively, following the approval of its biosimilars in the US and Europe in the first half... Full

Roche Changes Its Tune On 2025 Xolair Biosimilars Amid Celltrion's First Filing

(10/24, Dean Rudge, Generics Bulletin) ...In a volte-face, Roche has outlined that it anticipates no US biosimilars to its Xolair (omalizumab) asthma and chronic hives blockbuster in 2025 – despite key omalizumab formulation patents expiring in November next year...Other biosimilar sponsors currently developing a biosimilar to Xolair include Teva, which has wrapped up a Phase III clinical trial comparing its TEV-45779 candidate against the reference product in patients with chronic idiopathic urticaria/chronic spontaneous urticaria... Global Sub. Full

Roche CEO Says Novo's Catalent Buyout 'Could Be a Problem' for Smaller Drugmakers

(10/23, Fraiser Kansteiner, Fierce Pharma) ...Speaking to the press Wednesday, Roche's chief executive Thomas Schinecker critiqued the proposed transaction, arguing that it could hamper the ability of smaller biopharma players to lock down essential manufacturing capacity...Under the current plan, Novo Nordisk is in line to purchase three Catalent fill-finish facilities from Novo Holdings for $11 billion after the closure of Novo Holdings' Catalent purchase. "Novo Nordisk will honor all existing contracts at the Catalent sites," A Novo Nordisk spokesperson recently told Fierce Pharma... Full

Strides Pharma Science Q2 Results: Firm Posts Net Profit of Rs 93.66 Crore

(10/24, Press Trust Of India) ...Strides Pharma Science Ltd reported a consolidated net profit of Rs 93.66 crore for the second quarter of FY25, recovering from a Rs 149.45 crore net loss in the same period last fiscal. Revenue rose to Rs 1,201.11 crore, driven by new product launches and significant growth in US operations... Full

With Expanded FDA Nod for RSV Shot Abrysvo, Pfizer Gains Edge On GSK's Arexvy. But Will it Amount to Much?

(10/23, Kevin Dunleavy, Fierce Pharma) ...While it's a win for Pfizer over GSK and its RSV vaccine Arexvy, which is approved for those 50 and older, it's difficult to determine how much advantage will be gained from the nod as the Centers for Disease Control (CDC) will have to sign off on Abvrysvo's use in the wider age group... Full

FDA Recalls Thousands of Antidepressant Bottles Due to Cancer-Causing Chemical

(10/23, Alejandra O'Connell-Domenech, The Hill) ...The FDA noted that the drug had the "presence" of nitrosamine drug substance-related impurity above the acceptable intake limit...The agency is specifically recalling 7,107 bottles of duloxetine delayed-release capsules manufactured by Towa Pharmaceutical Europe. The capsules are 20 milligram doses and come in bottles of 500 pills... Full

Why Does an $84,000 Drug in the U.S. Cost Less Than $1,000 in India

(10/23, Web Golinkin, Forbes) ...The challenge will be to reign in prescription drug costs without removing all of the financial incentives that have helped to make our domestic pharmaceutical industry a world leader and critical part of the U.S. economy. This will be a tough balance to achieve, but it appears that all stakeholders recognize the urgent need for it to occur... Full

Watchdog: Why Former Mavs Majority Owner Mark Cuban is Focused On Drug Prices

(10/23, Dave Lieber, The Dallas Morning News) ...[Mark Cuban] We simply introduced transparency. We show our costs, our markup and our final price to patients. It's simple. But no one else publishes their complete price list... Sub. Req’d

Updating The IRA Math: Not As Bad For Pharma As It Looked?

(10/23, Michael McCaughan, Pink Sheet) ...The Congressional Budget Office "now expects the net prices of negotiated drugs to be 25% to 50% lower in 2031" as a result of the IRA. The other elements of the Part D redesign will generate more innovator drug sales than previously expected. Overall, the IRA will continue to have a significant impact on the industry... Global Sub. Full

Weight-Loss Drugs Didn't Curb Health Costs Within Two Years

(10/24, Chad Terhune, Reuters) ...Drugs like Wegovy may trim your waistline but not medical costs, according to an analysis of U.S. health insurance claims shared with Reuters. The full-year cost of care for U.S. patients with obesity two years after starting on Novo Nordisk's Wegovy or similar GLP-1 drugs was $18,507, on average. That represents a 46% jump over the average annual medical cost of $12,695 prior to taking the medication, data provided by pharmacy benefits manager Prime Therapeutics show... Full

Drug Makers Seek Agency, Court Actions To Forbid Compounding Of Their Products

(10/23, Gabrielle Wanneh, InsideHealthPolicy) ...Novo Nordisk wants FDA to place its three drug products with semaglutide as the active pharmaceutical ingredient on a list that would prohibit pharmacies and outsourcing facilities from further compounding the drugs due to the complex nature of their production. At the same time, Eli Lilly is suing two online vendors and a medical spa for selling compounded versions of the company's drugs with the API tirzepatide... Sub. Req’d

PBM Model is a ‘Dead Man Walking.' What Comes Next?

(10/23, Susanna Vogel, Healthcare Dive) ...Executives from healthcare organizations as varied as Amazon's online pharmacy, retailer Walgreens, insurer Blue Shield of California and drugmaker lobby PhRMA called for an end to the pharmacy benefit manager model during HLTH 2024, saying the middleman structure misaligns incentives and drives up costs of drugs... Full

PBM Math: Big Chains Are Paid $23.55 To Fill a Blood Pressure Rx. Small Drugstores? $1.51.

(10/24, Andy Miller, KFF Health News) ..."The differences in Georgia are unbelievable," Antonio Ciaccia, who runs Ohio-based consulting firm 3 Axis Advisors. "If you're a pharmacist, you don't have any control over which drugs you dispense and which you don't."... Full

Elon Musk Bungles His Criticism of U.S. Drug Regulators

(10/24, Adam Feuerstein, STAT Plus) ...While barnstorming across Pennsylvania recently in support of Donald Trump's presidential campaign, Elon Musk criticized the U.S. government for issuing too many rules and regulations. But in a twist on Musk's familiar lament, he cited the FDA and a cancer drug called Welireg, not rockets, electric cars, or satellites... Sub. Req’d

340B Sales Reach New Heights: Legislative Reform Prospects Depend On US Elections

(10/23, Cathy Kelly, Pink Sheet) ...Sales in the 340B outpatient drug discount program rose more than 23% to $66bn in 2023, continuing a long string of significant annual increases in spending. The news underscores the need for 340B legislative reform, critics say. But prospects for change depend on the outcome of the upcoming US elections. A Republican sweep in both chambers of Congress and the White House would offer the best chance for enacting legislative reform. And right now that seems possible... Global Sub. Full

Second Opinion: Big Pharma Once Again Tries to Defend the Patent Abuse Status Quo

(10/23, The Campaign for Sustainable Rx Pricing) ...In an opinion column published last week, Eli Lilly Chief Scientific Officer Daniel Skovronsky, M.D., Ph.D. argues the patent system is functioning and that lawmakers ought not to interfere with it. This defense of the status quo papers over Big Pharma's egregious abuse of the patent system designed to block competition, extend monopolies, and keep prescription drug prices high — and the impact on patients and the U.S. health care system...Let's get a Second Opinion on several of the claims made in Skovronsky's column... Full

Day Three of the AAM GRx-Biosims Conference

(10/23, Bob Pollock, Lachman Consultants) ...It is the last day of the conference, and we have some highlights for you. In a keynote address, Jacqueline Corrigan-Curay, J.D., M.D., Principal Deputy Center Director, Center for Drug Evaluation and Research provided a State of the Biosimilars and Generics Program... Full

Calling for Unified Biosimilar Standards, Stronger Education at GRx+Biosims

(10/23, Skylar Jeremias, The Center For Biosimilars) ...During a fireside chat at the GRx+Biosims conference, Sarah Yim, MD, director of the FDA's Office of Therapeutic Biologics and Biosimilars (OTBB), stressed the need for stronger education efforts and industry collaboration to boost trust and streamline the path to biosimilar adoption... Full

Stakeholders: Diverse Trials Can Strengthen Understanding Of Drugs

(10/23, Luke Zarzecki, InsideHealthPolicy) ...Increasing diversity may also lead to breakthrough therapies for conditions with small patient populations, according to a leading rare disease patient advocacy group. However, several commenters on FDA's draft guidance warned its enrollment goals may be unrealistic for at least some patient populations... Sub. Req’d

FDA Drafts Guidance On Drug Interaction Labeling

(10/23, Jeff Craven, Regulatory Focus) ...The US Food and Drug Administration (FDA) has released a new draft guidance describing what should and should not be included in the Drug Interactions (DIs) section for human prescription drug and biological product labeling as well as how drug interaction information should appear in other areas of the product's labeling... Full

Minnesota Defends Drug Price Law in Appeal of Lower Court Pause

(10/23, Celine Castronuovo, Bloomberg Law) ...A federal appeals court ruling against a Minnesota drug pricing law could open the door to litigation questioning the state's authority to regulate medicines within its borders, a state attorney said in oral arguments Wednesday... Sub. Req’d

Urgent Review Of EU Urban Wastewater Treatment Directive Unlikely, Despite Industry Concerns

(10/23, Francesca Bruce, Pink Sheet) ...The European pharmaceutical industry is calling for an urgent review of the updated EU Urban Wastewater Treatment Directive, which it says places an unfairly large burden on the pharmaceutical and cosmetic industries to clean up micropollutants... Global Sub. Full

Déjà Vu In England: Lilly's Alzheimer's Drug Kisunla Gets MHRA Yes, But NICE Says No

(10/23, Eliza Slawther, Pink Sheet) ...The reimbursement blow for Kisunla came on the same day that it was authorized by the MHRA for the treatment of patients with the early stages of Alzheimer's disease who have one or no copies of the apolipoprotein E4 (ApoE4) gene. This rejection from NICE is provisional and subject to a public consultation which will close on November 20,. A second meeting of NICE's appraisal committee will be held on January 15, next year, followed by final guidance on March 26... Global Sub. Full

EMA Discusses Disruptive Impact Of ‘Bad Submission Planning' By Pharma

(10/23, Vibha Sharma, Pink Sheet) ...The European Medicines Agency has shared real-life examples of how poor planning by companies results in repeated delays to their planned marketing authorization applications, which in turn causes a drain on resources. When it comes to submitting plans for a drug marketing authorization application for evaluation via the EU's centralized procedure, the European Medicines Agency says there are clear examples of "good and bad behavior" from companies that can affect the efficiency of its processes... Global Sub. Full

DoP Rejects Review Applications from Five Companies On Pricing of Modified Release Metoprolol

(10/24, Pharmabiz.com) ...The has rejected review applications from five companies including AstraZeneca and Lupin while upholding the ceiling price fixed for various strengths of modified release formulations of high blood pressure drug metoprolol. AstraZeneca, Lupin, Macleods Pharmaceuticals, Ajanta Pharma, and Primus Remedies approached the DoP with separate review applications against the ceiling price fixation of the formulation, with similar arguments related to the price fixation of the extended or modified release format... Full

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