Monday, March 18, 2024

As Humira Biosimilars Take Over The Market, CVS Has Created a New Ploy: The Drug ‘Rebate Credit'

(3/18, Bob Herman, STAT Plus) ...Knowing that drug rebate dollars from Humira would evaporate as more biosimilars catch on, since there are usually no rebates on biosimilars, CVS told its clients it would calculate their rebates in a new way - using a complicated explanation and formula that protects CVS' profit, those experts said..."The PBMs are trying to recoup lost rebates and lost profits," said Paul Holmes, an attorney at Williams Barber Morel who works with employers on their PBM contracts and who reviewed CVS' documents at STAT's request. "They're sort of saying you have to suffer the loss of the rebates, and you have to pay us back because we didn't get our portion of the rebates."... Sub. Req'd

Adalimumab Expenditures in Countries With and Without Available Biosimilars

(3/16, Deana Ferreri, PhD, The Center For Biosimilars) ...A recent study used difference-in-difference analysis to assess adalimumab sales volumes and expenditures in 6 countries with available biosimilar adalimumab products and 8 countries without.In countries with adalimumab biosimilars, the authors reported adalimumab expenditures decreased while consumption was maintained or increased. Based on their findings, the introduction of adalimumab biosimilars is expected to result in budget savings of $371 per gross domestic product per capita during the first year, alongside an increase of 1.0 standard units in treatment accessibility per 1000 population... Full

Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars

(3/17, Skylar Jeremias, The Center For Biosimilars) ...On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition... Full

Formycon Builds On Middle Eastern Ranibizumab Plans With Saudi Approval

(3/15, Adam Zamecnik, Generics Bulletin) ...The Saudi Food & Drug Authority has authorized Formycon's FYB201 biosimilar to Roche's Lucentis (ranibizumab), stepping up the product's rollout across the Middle East and North Africa region. While the biosimilar will become ready in the country in the second quarter of 2024, Formycon and its regional partner MS Pharma are already planning additional launches later this year. This includes in Algeria and countries in the Gulf Cooperation Council... Global Sub. Full

Formycon and Fresenius Kabi Reach Settlement Agreement for Ustekinumab Biosimilar Candidate FYB202 in Europe and Canada

(3/18, Formycon AG) ...Nicola Mikulcik, Chief Business Officer of Formycon AG, commented: "Achieving this settlement is testament to our strategic approach of ensuring we make early preparations to expand patient access to critical treatments. Our aim is to make a significant difference in patients' lives by providing them with reliable, high-quality, and affordable treatment options. Following the settlement for the US, this is another important step that underlines the joint effort of Formycon and Fresenius Kabi, and it solidifies our position to make FYB202 accessible in key global markets."... Full

Coherus: Udenyca Trajectory ‘Unknown' But ‘Compelling' With On-Body Launch

(3/15, Dean Rudge, Generics Bulletin) ...Coherus BioSciences has spoken in detail about its full suite of Udenyca pegfilgrastim biosimilar products and how it plans to return to growth and positive cash flow moving forward - although it cannot, for now, provide an estimate for 2024 revenues..."I think the primary issue is that we have freshly launched the Udenyca Onbody. We're very excited about the enthusiasm that's been received in the market. But the ultimate trajectory of that across 2024 is not yet known," acknowledged Coherus' chairman and CEO, Denny Lanfear... Global Sub. Full

Celltrion Launches Zymfentra in US, Setting Wholesale Cost at $6,181.08 for 2 Doses

(3/18, Lee Han-soo, Korea Biomedical Review) ...Celltrion officially launched Zymfentra, also known as Remsima SC in Europe, in the U.S., last Friday. Zymfentra is the world's only subcutaneous (SC) form of infliximab, having received FDA approval in October of the previous year. Under the approval, the drug can treat moderate to severe active ulcerative colitis and Crohn's Disease in adults, with a recommended dosage of 120mg every two weeks... Full

Lundbeck's Progresses First-in-Class Therapy for Migraine Prevention

(3/15, The Pharma Letter) ...Danish CNS specialist Lundbeck today announced the advancement of the clinical development of for migraine prevention with the initiation of PROCEED, a randomized, double-blind, Phase IIb, dose-finding trial to assess efficacy and safety of multiple subcutaneously administered doses...By 2027, the preventive migraine segment is forecast to be worth $10.1 billion, with a compound annual growth rate of CAGR of 11.3%. If approved, Lu AG09222 will compete with Lunbeck's own drug Vyepti (eptinezumab), as well as AbbVie's Qulipta (atogepant) and Eli Lilly Emgality (galcanezumab) and Rayvow (lasmiditan), as well as other drugs... Sub. Req'd

Lupin Gets USFDA Nod to Market a Generic Drug to Treat Bacterial Infections

(3/15, Press Trust Of India) ...Drug maker Lupin on Friday said it has received approval from the US health regulator to market a generic medication to treat bacterial infections, in America. The company has received approval from the USFDA for Doxycycline for Injection USP, the Mumbai-based drug maker said in a statement... Full

Zydus Rreceives USFDA's Final Nod for Finasteride, Tadalafil Capsules; Qualifies for CGT Exclusivity

(3/16, Money Control) ...Zydus Lifesciences Limited has obtained final approval from the United States Food and Drug Administration to market its Finasteride and Tadalafil Capsules USP 5 mg/5 mg (USRLD: ENTADFI TM), the company announced in an exchange filing on March 16. Notably, Zydus is the "first approved applicant" for Finasteride and Tadalafil Capsules, 5 mg/5 mg, as per section 505(j)(5)(B)(v)(III) of the FD&C Act, qualifying for 180 days of Competitive Generic Therapy exclusivity, it mentioned in the filing... Full

Aurobindo Pharma Arm CuraTeQ Announces Omalizumab Biosimilar Candidate BP11 Meets Phase 1 Trial End Points

(3/16, Pharmabiz.com) ...CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Ltd, announced that their omalizumab biosimilar candidate BP11 has met the phase 1 trial end points vis-à-vis the EU and US sourced reference product Xolair. The PK/PD trial was conducted in 165 healthy volunteers in Australia and New Zealand... Full

Viatris Generic Hypertension Drug Does Not Violate J&J Patents, US Court Says

(3/15, Blake Brittain, Reuters) ...U.S. District Judge John Bailey agreed with Viatris' Mylan Pharmaceuticals that its generic of Veletri would not include a patented element of the name-brand drug made by J&J subsidiary Actelion Pharmaceuticals, clearing a hurdle for the release of Viatris' proposed drug. The ruling follows a U.S. appeals court's decision to revive the case last year after finding that Bailey may have misinterpreted key parts of J&J's patents... Full

Israeli Startup to Use AI to Transform Antibody Discovery, Design

(3/17, Maayan Jaffe-Hoffman, The Jerusalem Post) ..."The launch of CombinAble heralds a shift in the approach to targeted antibody design by leveraging AI to optimize and expedite the discovery process," said Mati Gill, CEO of AION Labs. AION Labs is an Israeli venture studio operating in partnership with AstraZeneca, Merck, Pfizer, Teva, the Israel Biotech Fund, Amiti Ventures, and Amazon Web Services...CombinAble is tackling the drug discovery challenge with a platform that combines advanced AI technology and computational methods for biomolecule simulations, AION Labs explained... Full

Spanberger, Bacon Lead Bipartisan Bill to Create an Emergency Reserve of Active Pharmaceutical Ingredients, Strengthen Essential Medicine Supply Chain

(3/15, Congresswoman Abigail Spanberger) ...Spanberger and Bacon's Promoting Readiness and Ensuring Proper Active Pharmaceutical Ingredient Reserves of Essential Medicines (PREPARE) Act would help strengthen America's domestic pharmaceutical supply chain. Specifically, their legislation would require the Secretary of the U.S. Department of Health and Human Services to maintain a list of essential generic medicines and create an emergency supply of the API necessary for those medicines — with a preference for American manufacturers and contractors... Full

Lankford Calls for Senate Leadership to Act Immediately to Lower Cost of Prescription Drugs

(3/15, U.S. Senator for Oklahoma James Lankford) ...Senator James Lankford (R-OK) today sent a letter to Majority Leader Chuck Schumer (D-NY) and Minority Leader Mitch McConnell (R-KY) to call for immediate action on reforming pharmacy benefit managers in an effort to reduce the cost of prescription drugs... Full

Inflation Reduction Act and the Impact On Biosimilars

(3/15, Diankaren Balasubramanian, Contract Pharma) ... The Inflation Reduction Act which was signed into law in August 2022 announced several provisions on prescription drugs, with the aim of lowering the burden on people and reducing federal spending on drugs. Some of these provisions are targeted at high-cost biologic drugs, which are in turn expected to have a profound impact on the market dynamics for biosimilars. Direct price negotiation with manufacturers is one of the major policy changes that has been analyzed in detail. In this article the attempt is to focus on nuances around some of the other provisions and their impact to biosimilars... Full

Medicare Managed Care Plan Costs Continue to Spiral, Panel Finds

(3/15, Tony Pugh, Bloomberg Law) ...Medicare will spend $83 billion more this year to care for beneficiaries in private Medicare Advantage plans compared to the cost of care in the traditional fee-for-service program, according to an advisory committee report released Friday. The Medicare Payment Advisory Commission's annual March report to Congress says the 22% cost difference stems from two factors: aggressive "coding" of potential illnesses by Medicare Advantage providers; and "favorable selection," the movement to MA plans of beneficiaries with substantially lower costs than predicted... Sub. Req'd

The White House Wants to Double Dip on Drug Rebates

(3/15, Tomas Philipson, RealClearHealth) ...As part of its "Strike Force on Unfair and Illegal Pricing," the White House just doubled down on a December plan to allow the federal government to tear up exclusive patent agreements between innovative drug companies and research universities...This ignores how federal research funding works and what it is designed for - and also ignores the fact that the government already reaps benefits, and tax revenue, from the increased public health improvements and economic activity caused by drug innovation. Evidently that's not enough, and the government wants to double-dip... Full

Drug Price Shenanigans

(3/15, Grace-Marie Turner, RealClearHealth) ...Penalizing drugmakers means they will be less likely to invest hundreds of millions of dollars and decades into research and development, leading to fewer treatments," writes Joel White of the Council for Affordable Health Coverage writes in RealClearHealth. "That means people will be sicker, and costs will go up, not down." Former White House Economist Tomas Philipson estimates President Biden's price control scheme will mean 135 fewer drugs over the life cycle of drug development, resulting in 330 million lost life years in the U.S. from patients who could have been treated or cured from drugs that were never developed... Full

Artificial Intelligence: US FDA Plans Guidances On Algorithm Bias, Product Development

(3/15, Derrick Gingery, Pink Sheet) ...Cross-center AI strategy features collaboration between drug, biologic, device and combination product staff to ensure regulatory predictability. ‘Assurance labs' offering independent valuation of models should be available by year-end as part of FDA's involvement with Coalition for Health AI... Sub. Req'd

Should Michigan Get into the Insulin Business? Dropping Market Prices Could Thwart Plan

(3/15, Dustin Walsh, Crain's Detroit Business) ...With 13% of the Michigan population living with diabetes, state legislators are embarking on a bold strategy to ensure ample production and affordability of insulin. Yet insulin prices are dropping thanks to the introduction of generic and biosimilar insulins, as well as recent federal government intervention. And while there is a precedent for a state-run insulin brand - California announced its plans in 2023 - the effort has not yet brought its drug to market... Full

Health Spending Spikes in Massachusetts Amid High Drug Expenses, Unprecedented Patient Cost Sharing, Regulator Warns

(3/15, Dave Muoio, Fierce Healthcare) ...The Bay State's total healthcare expenditures per capita increased by 5.8% from 2021 to 2022, well above the national rate of 4.1% and nearly double the 3.1% benchmark set by the Massachusetts Health Policy Commission based on prior years' compounded growth. The jump translates to a new total of $10,264 in average healthcare spending per resident, according to a report issued by the commission's Center for Health Information and Analysis on Thursday. Healthcare spending in the state has consistently exceeded prior years' benchmarks since 2017... Full

EU Reaches Last-Minute Agreement On Health Data Space After Tough Negotiations

(3/15, Eliza Slawther, Pink Sheet) ...A provisional political agreement on the creation of the European Health Data Space has been reached two days after the European Parliament, the European Commission and the Council of the EU announced they had failed to agree on certain aspects of the new regulation during their last round of negotiations...A spokesperson for the European pharmaceutical industry federation EFPIA told the Pink Sheet that it would review the provisional agreed version of the EHDS text and provide an update on how the regulation will affect the pharma industry in due course... Sub. Req'd

European Parliament Clears EU-Wide Compulsory Licensing Proposal

(3/15, Ian Schofield, Generics Bulletin) ...The draft regulation, which includes a ban on exports of drugs manufactured under an EU compulsory license, will be discussed with the EU member states after the June parliamentary elections. Members of the European Parliament have given the green light to new rules that they say will "ensure the EU's access to key patented products in times of crisis" by allowing the European Commission to issue EU-wide compulsory licenses on originator drugs and other products such as microchips... Global Sub. Full

European Parliament Committee Proposes Changes to Pharma Legislation

(3/15, Nick Paul Taylor, Regulatory Focus) ...The European Parliament's health committee is set to debate and vote on changes to the proposed pharmaceutical legislation on March 19, including provisions that would increase market exclusivity and regulatory data protection compared to the European Commission's proposal released last year... Full

EC Defends Data Protection Cut As EU ‘Pharma Package' Nears Crucial Milestone

(3/15, Ian Schofield, Pink Sheet) ...The European Commission has published a set of "fact sheets" in which it sets out what it sees as the benefits of its proposed reform of the EU pharmaceutical legislation, including the controversial plan to reduce the default period of regulatory data protection (RDP) on new drugs. The four fact sheets, which also discuss plans to guide drug development towards unmet needs and to tackle drug shortages more effectively, can be seen at least partly as the commission's response to criticisms that have been leveled at the so-called "pharmaceutical package."... Sub. Req'd

Expert Perspective On Overcoming the Difficulties of Cold Chain Logistics in India's Pharma Sector

(3/15, Rashmi Mabiyan and Prarthana Sharma, ET HealthWorld) ...In the pharmaceutical industry, preserving product integrity across the supply chain is crucial. Because it frequently puts lives in danger, production facilities and end users alike must ensure accurate temperature management. Despite the inherent complexity of cold chain logistics, there are plenty of chances for innovation and integration to effectively address these difficulties... Full

Sequential Rise in US Biz Bolsters Pharma Cos' Fortunes

(3/18, Niyati Parikh, Times Of India) ...Over the past three quarters – from April to Dec 2023 – key players in the pharma industry have witnessed significant growth in their US market business, marking a positive turn in their fortunes. Industry insiders reveal that alongside the Indian market, the US market has been a primary driver of revenue growth for these major companies. For instance, Zydus Lifesciences Limited recorded a robust double-digit growth of 18.7% in its US formulations business during this period compared to the same timeframe in 2022. Similarly, Sun Pharmaceuticals Limited saw a 13.9% increase in its US market revenues, while Alembic Pharmaceuticals reported a 7.5% growth in its US business revenues for the first three quarters of the fiscal year... Full

India's NPPA Struggles to Recover Over 86% of Overcharging Demands

(3/15, The Pharma Letter) ...More than 86% of the National Pharmaceutical Pricing Authority's total demand for overcharging remains unrecovered from drug majors operating in India. The NPPA, tasked with monitoring and controlling drug prices in the country, has been struggling to enforce ceiling prices, with several pharmaceutical companies allegedly overcharging for life-saving drugs... Sub. Req'd

Medical Devices Makers Worried Over Wider Price Controls in the Offing

(3/18, Manu Kaushik, Financial Express) ...The department of pharmaceutical has formed a five-member committee to review the pricing framework for drugs and medical devices...Industry experts suggest that the new policy will have a huge impact on the medical devices industry since a large number of devices will likely come under the price control. At the moment, the National Pharmaceutical Pricing Authority controls prices of just a few of the 6,000-odd medical devices sold in the country. This number is expected to go up significantly under the new policy... Full

Bio-Thera Solutions Partners with SteinCares to Market Two Biosimilars in LATAM

(3/18, Bio-Thera Solutions) ...Bio-Thera Solutions, a commercial-stage biopharmaceutical company developing innovative therapies and biosimilars, and SteinCares, one of Latin America's leading specialty healthcare companies, announced today a new licensing agreement for two biosimilars under which SteinCares will have exclusive rights to distribute and market Bio-Thera's pharmaceuticals in Brazil and the rest of the region... Full

Big Pharma Shakeup in Morocco As Sanofi Sells Business to Hikma

(3/17, Hespress English) ...The Competition Council in Morocco has begun examining a deal in which Sanofi, a French pharmaceutical giant, will transfer its Bleomycin cancer drug business to Hikma, a UK-based international pharmaceutical company, Hespress AR reported. This transfer will specifically impact Hikma's Moroccan subsidiary, Promopharm. This deal comes when Bleomycin drugs have faced severe pharmacy shortages, with prices starting at 345 DH, Hespress AR reported... Full

Russia Plans to Speed the Replacement of Imported Drugs by Domestic Generics

(3/15, The Pharma Letter) ...Russia plans to speed the replacement of imported drugs by domestic generics with the aim of raising state security in the field of pharmaceutics and drugs assistance, reports The Pharma Letter's local correspondent. This will be part of the existing state strategy for the "Development of Pharmaceutical Industry in Russia until 2030," the main legislative act, which regulates the development of pharmaceutical industry in Russia within the next six years... Sub. Req'd

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