Tuesday, August 13, 2024

Generics Bulletin Explains: US Adalimumab Outlook Brightens At Mid-Point Of 2024

(8/12, David Wallace, Generics Bulletin) ...The latest figures on uptake for rivals to Humira in the US show adalimumab biosimilars beginning to capture significant market share from the originator, AbbVie's Humira, after an initially slow start in 2023...Meanwhile, the early 2024 launch by Teva and Alvotech of their long-awaited but repeatedly delayed interchangeable high-concentration 100mg/ml Humira rival, Simlandi, was accompanied by the firms revealing a private-label deal with Evernorth's Quallent Pharmaceuticals. Alvotech and Teva were not the only firms to agree a deal with Quallent, as Boehringer also signed up to allow an unbranded version of its own adalimumab biosimilar to be provided via the Evernorth unit... Global Sub. Full

Viatris Aims To Be At The Vanguard For Mammoth GLP-1 Opportunities

(8/13, Dean Rudge, Generics Bulletin) ...Viatris anticipates having a "significant role going forward" in the upcoming off-patent GLP-1 obesity and diabetes market, underlining that it has secured a crucial – yet unspecified – supply of active pharmaceutical ingredient for its planned assets and "certainly have invested in our capability to manufacture."...Teva, however, stepped ahead of Viatris in the race in June, launching an authorized generic of the type 2 diabetes treatment Victoza in the US under the terms of a settlement agreement with originator Novo Nordisk. "Victoza is an exciting opportunity, the first GLP-1 into the market," Teva told investors during its own second-quarter earnings call... Global Sub. Full

Sandoz Bolsters US Ophthalmic Portfolio With Aflibercept Approval

(8/12, David Wallace, Generics Bulletin) ...Sandoz has notched up another US Food and Drug Administration biosimilar approval, this time for its Enzeevu (aflibercept-abzv) rival to Regeneron's Eylea. However, a complicated intellectual property landscape and court proceedings around the ophthalmic brand mean that launch timing remains uncertain... Global Sub. Full

Introducing Jubbonti® and Wyost®, The First Denosumab Biosimilars On the Canadian Market

(8/12, Sandoz) ...Sandoz Canada, a leader in generics and biosimilars, today announces the launch of two denosumab biosimilars: Jubbonti® and Wyost®...Jubbonti® is approved for all indications of its reference medicine Prolia® while Wyost® is approved for all indications of its reference medicine Xgeva®. "It is great news that Canadians will now have access to high-quality denosumab biosimilars. This launch reflects our deep commitment to our Purpose of pioneering access for patients, as Sandoz Canada is the first and only company to offer these biosimilars in the country."... Full

Formycon Reports a Strong First Half-Year with Multiple Milestones Achieved

(8/13, Formycon AG) ...Successful business development characterized by key operational, clinical, and regulatory milestones. Group revenue and EBITDA in line with expectations. Operating results of FYB201 in the first half of the year significantly exceeded expectations, leading to an increase of the adjusted EBITDA guidance. Acceleration in the European approval process of FYB202 and the associated early milestone payment will lead to a significant increase in working capital in 2024... Full

US Court Pulls No Punches At It Denies Novartis Bid To Block MSN's Entresto Generic

(8/13, Dean Rudge, Generics Bulletin) ...A US district court handed victory to MSN Laboratories Pvt. Ltd. yesterday, August 12, as it denied Novartis' request for a preliminary injunction blocking the sale of MSN's US Food and Drug Administration-approved version of the Swiss originator's $3bn Entresto (sacubitril/valsartan) heart failure brand. However, Delaware district court judge Richard Andrews also imposed a brief stay to allow Novartis to seek injunctive relief from the US Court of Appeals for the Federal Circuit, with the expectation that Novartis would do so immediately while also filing emergency motions in the Federal Circuit as "soon as possible."... Global Sub. Full

Novartis Takes Fight To The FDA After US Entresto Generic Approval

(8/12, Dean Rudge, Pink Sheet) ...Novartis AG has swiftly filed suit against the US Food and Drug Administration after the agency's denial of a second citizen petition opened the door for what the Swiss originator company claims is an "unlawful" approval of a generic version of its Entresto (sacubitril/valsartan), the $3bn heart failure powerhouse... Sub. Req'd

Novo Nordisk Gears Up for FDA Filing with Late-Phase Insulin Plus Semaglutide Data

(8/12, Ayisha Sharma, Endpoints News) ...Novo Nordisk, with data on-hand from a late-stage trial of IcoSema, is preparing for an FDA filing in type 2 diabetes slated for the second half of the year. IcoSema is a combination of Novo's insulin icodec and GLP-1 agonist semaglutide. Last week, the Danish drugmaker said the once-weekly injection achieved an average 1.6% reduction in the primary endpoint of change in HbA1c level at 52 weeks versus a 0.9% drop for insulin icodec... Full

Alembic Pharma Receives USFDA Approval for Dabigatran Etexilate Capsules

(8/13, Business Standard) ...Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration for its Abbreviated New Drug Application Dabigatran Etexilate Capsules, 110 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product, Pradaxa Capsules, 110 mg of Boehringer Ingelheim Pharmaceuticals, Inc. (Boehringer)... Full

Pfizer, Looking to Expand RSV Vaccine's Reach, Touts its Benefits in Immunocompromised Adults

(8/12, Angus Liu, Fierce Pharma) ...Monday, Pfizer said Abrysvo elicited a strong response in adults of various ages with compromised immune systems. A single dose of the vaccine generated strong neutralizing antibodies against both subtypes of RSV across all cohorts, Pfizer said, even though the phase 3 study, coded MONeT, tested Abrysvo in two doses given one month apart. Based on the positive readout, Pfizer said it plans to submit the data to regulators for review and share the full details at an upcoming scientific conference... Full

Dr Reddy's Labs Shares Drop After US FDA Gives VIA Tag to Vizag Facilities

(8/12, Business Standard) ...Shares of Dr Reddy's Laboratories slipped up to 2 per cent at Rs 6,875.05 per share on the BSE in Monday's intraday trade. This came after the United States Food and Drug Administration issued an establishment inspection report (EIR) to the company, for its manufacturing facilities (FTO-7 and FTO-9) in Duvvada, Visakhapatnam, Andhra Pradesh... Full

Celltrion Begins Yuflyma Sale at Costco in US

(8/13, Kim Chan-hyuk, Korea Biomedical Review) ...Celltrion said Tuesday that U.S. retailer Costco has begun selling its Humira biosimilar Yuflyma (adalimumab)...According to the U.S. Centers for Disease Control and Prevention, as of the first quarter of 2024, there were about 27.1 million uninsured Americans. These individuals have had difficulty accessing expensive treatments, but now Costco members can purchase Yufluma at 85 percent off the original price with additional discounts... Full

Study: Sales Price of Originator Declines After Introduction of Biosimilars

(8/12, Ashley Gallagher, Pharmacy Times) ...The average sales price of both originators and biosimilars declined significantly after the introduction of biosimilars, according to a study published in Health Affairs Scholar. Investigators found that this could suggest the biosimilar uptake alone may not be a complete measure of the market competition and lowering prices... Full

Budget Impact Analysis Finds Cost Savings When Switching to Humira Biosimilars

(8/12, Rosanna Sutherby, Pharm.D., Managed Healthcare Executive) ...According to a study, increased competition brought about by the emergence of biosimilars in the market has resulted in a CAGR decrease of 5% to 20% in biosimilar and reference product pricing. It is estimated that biosimilars have saved payers, and in the end patients, more than $100 billion over five years... Full

Color-Coded Asthma Medication Labels in Pharmacies Enhance Self-Management Education

(8/12, Gillian McGovern, Pharmacy Times) ...Pharmacists play a critical role in the improvement of medication adherence and self-management, particularly in the asthma space. Improper use and understanding of these medications may result in poorly controlled asthma, emergency room visits, or hospitalizations for younger children who have asthma. The use of color-coded labels to help patients differentiate between rescue and maintenance inhalers have not been explored; therefore, authors of a study published in PEC Innovation aimed to assess feasibility of labeling asthma inhaler medications at both local and regional pharmacies... Full

Springfield Doctors Still Seeing a Shortage of ADHD Medications; Causes Behind the Issue

(8/12, Savannah Harrison, KY3) ...Dr. Barbe says several issues are contributing to the problem, the biggest being the increased demand for ADHD medications. "We see the diagnosis of ADHD in children going up a couple of percent per year, but the largest growth has been in ADHD in adults. We're seeing upwards of 10 to 15% new cases diagnosed in adults each year," said Dr. Barbe. Along with that, supply chain issues and production caps are affecting the way pharmacies can get medications... Full

Lawmakers Renew Calls for Government to Finalize March-In Guidance

(8/12, Nicole DeFeudis, Endpoints News) ...Sens. Elizabeth Warren (D-MA) and Angus King (I-ME), and Rep. Lloyd Doggett (D-TX) are once again urging the federal government to "immediately strengthen and finalize" the Biden administration's guidance around march-in rights... Full

Pending Government Drug Pricing Will Harm Seniors' Care And Budgets

(8/12, Sally Pipes, Forbes) ...Any day now, the Biden administration will publish the prices it has set for ten drugs covered by Medicare's Part D prescription drug benefit. These price controls will provide "meaningful financial relief for millions of people with Medicare," administration officials say. Many seniors are about to see just how false that promise is. Millions of beneficiaries won't see a nickel in relief at the pharmacy counter. In fact, their costs will go up... Full

CMS Should Do More To Fulfill The IRA's Promise To Lower Drug Costs For Patients

(8/12, A. Mark Fendrick, Health Affairs) ...The Inflation Reduction Act (IRA) could make prescription drugs more affordable for millions of US seniors. While many Medicare beneficiaries have heard about the law's drug price negotiation provision intended to generate savings for Medicare, that's not where the real action is on improving patient affordability... Full

Big Pharma Highlights How PBMs Secure Significant Savings On Prescription Drugs

(8/12, PCMA) ...While Big Pharma continues to push lawmakers to pass misguided policies to undermine PBMs and the tools they use to drive down costs, the financial analysts and earnings reports from some of the most powerful drug companies show that PBMs are effective in leveraging scale to negotiate with drug companies to lower costs for patients and families... Full

Q&A: Unveiling the Current State of PBMs' Role in Independent Pharmacy

(8/12, Brian Nowosielski, Drug Topics) ...Tom DePietro, PharmD, owner of DePietro's Pharmacy in Dunmore, Pennsylvania, discussed the current state of independent pharmacy and the role pharmacy benefit managers play within the supply chain... Full

BioRationality: Bill to Remove Double Patenting that Harms Biosimilars Heads to the House

(8/12, Sarfaraz K. Niazi, PhD, The Center For Biosimilars) ...Sarfaraz K. Niazi, PhD, argues that the S-150 bill, also known as the "Affordable Prescriptions for Patients Act of 2023," aims to reduce drug prices by addressing anti-competitive practices such as patent thickets and product hopping, which hinder the entry of cheaper biosimilars and generics into the market... Full

PhRMA: NIH's Plan To Limit Price Via Licensing Will Chill Collaboration

(8/12, Maaisha Osman, InsideHealthPolicy) ...The drug industry lobby is arguing that the National Institutes of Health's (NIH) first-ever proposal to use its licensing process to ensure medical products are affordable by keeping U.S. prices equal to those in other developed countries would discourage collaboration between NIH and the private sector... Sub. Req'd

Pressure from Anti-China Legislation Begins to Ripple Through Biopharma

(8/12, Zachary Brennan, Endpoints News) ...A latest round of SEC filings from biopharma companies shows at least a dozen companies highlighting the Biosecure Act as a major incoming risk, as they would have to transition away from many Chinese suppliers over the next eight years. While it's not certain that the bill will become law, some companies are already taking closer looks at their supply chains... Full

Legal Experts Note Confusion About DSCSA Waivers, Exceptions, and Exemptions

(8/12, Joanne S. Eglovitch, Regulatory Focus) ...Attorneys said one of the top concerns cited by clients are the timing of submitting waiver, exception, and exemption requests (WEE) as well as some general confusion on what constitutes a WEE request under the Drug Supply Chain Security Act during a recent webinar sponsored by the Healthcare Distribution Alliance (HDA)... Full

Coloradans Burdened by Health Care Costs, Survey Finds

(8/12, Angeline McCall, 9 News) ...More than 1,400 people in Colorado shared their concerns about healthcare affordability in a survey conducted by the Colorado Consumer Health Initiative (CCHI) and Altarum Health Care Value Hub..."Patients are generally still concerned about rising hospital prices, rising prescription drug prices and they're fearful for they're afraid of rising costs, and if they're going to be like able to afford their their healthcare in the future," said Priya Talang, spokesperson for the CCHI... Full

NHS Launches ‘Subscription' Scheme for Antibiotics with Pharma Sector

(8/12, Ian Johnston, Financial Times) ...The NHS will agree subscription-style deals with drugmakers for antibiotics, as the UK seeks to encourage the development of new medicines and curb antimicrobial resistance caused by their overuse. The NHS on Monday said it would negotiate fixed fees to pharmaceutical companies of up to £20mn a year per drug, working alongside the National Institute for Health and Care Excellence, the health spending watchdog... Sub. Req'd

India's Opportunity to Lead the Future of Healthcare Delivery Drives Through Sustainable Pharma Cold Chain and Storage

(8/13, Sandeep Gupta, Express Pharma) ...Unprecedented environmental, energy, and pharmaceutical safety regulations have created a labyrinth of challenges for the pharmaceutical industry and the healthcare ecosystem. Stewardship with sustainable and digital-first deployments will help major stakeholders—governments, providers, and patients—successfully navigate today's cold chain complexities and access the right drug at the right time... Full

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