Tuesday, August 6, 2024

‘2024 Is The Year Of Financial Progression,' Says Fresenius As Biosimilars Revenues Jump 102%

(8/5, Urte Fultinaviciute, Generics Bulletin) ..."We are a simpler, stronger, and more focused company. 2024 looks to be a great year with excellent financial progression," Fresenius' CEO Michael Sen did not hide his enthusiasm about the future during the firm's recent Q2 investors call. Fresenius Kabi's biopharma division, which is one of the three growth vector segments alongside nutrition and MedTech, reported "excellent" organic revenue growth of 102%, bringing in €150m ($162.5m) in Q2 2024, influenced by licensing agreements at mAbxience, a majority stake in which was acquired by the firm in 2022... Global Sub. Full

Cigna CEO David Cordani: 'Biosimilars Represent a Force of Change and Opportunity for Continued Growth'

(8/5, Susan Morse, Healthcare Finance) ...Specialty and Care Services showed strong growth with revenue up 18% to $22.9 billion, and pre-tax adjusted earnings were up 12% to $756 million, at the high end of the company's long-term target growth range, said Brian Evanko, CFO and president and CEO Cigna Healthcare...By 2030, an additional $100 million of annual specialty drug spend in the U.S. will be subject to biosimilar and generic competition, Cordani said. In the U.S., there are already more than 20 gene therapy and cell therapies available with nearly 1,000 more in the pipeline... Full

Lupin Completes Phase 3 Study of LUBT010, A Biosimilar Candidate to Lucentis

(8/5, Pharmabiz.com) ...Global pharma major Lupin Limited announced the successful completion of a global phase 3 clinical study of LUBT010, its biosimilar candidate to Lucentis. The study has achieved its primary endpoint of therapeutic equivalence in visual acuity improvement for wet AMD patients, showcasing comparable safety and immunogenicity between LUBT010 and Lucentis... Full

Celltrion's CT-P41 Shows Equivalent Efficacy to Prolia in Global Phase 3 Trial

(8/6, Choi Mun-hee, Business Korea) ...Celltrion has announced the publication of the results from a global Phase 3 clinical trial for its biosimilar "CT-P41" in the international journal "Osteoporosis Internationa."...A representative from Celltrion stated, "As we have reconfirmed the efficacy and safety of CT-P41 compared to the original drug, we will do our best to ensure that the ongoing approvals in major global countries proceed without any issues."... Full

Lilly Korea's New Atopic Dermatitis Drug ‘Ebglyss' Receives Approval

(8/6, Lee Han-soo, Korea Biomedical Review) ...Elli Lilly Korea said its new atopic dermatitis drug Ebglyss (ingredient: lebrikizumab), an Interleukin (IL)-13 inhibitor, received approval from the Ministry of Food and Drug Safety on Monday...Ebglyss is approved for treating moderate to severe atopic dermatitis in adults and adolescents 12 and older weighing over 40 kg, who are inadequately controlled with topical prescription therapies or for whom those therapies are not advisable... Full

Biocon Facility Gets Inspection Report From US FDA, Voluntary Action Indicated

(8/5, Prajwal Jayaraj, NDTV Profit) ...Biocon Ltd.'s active pharmaceutical ingredient facility received an Establishment Inspection Report with Voluntary Action Indicated from the US Food and Drug Administration, according to an exchange filing on BSE. The facility is located in Visakhapatnam, Andhra Pradesh..."Biocon remains committed to the quality, Safety and efficacy of the products manufactured," the company said in a statement in the exchange filing... Full

GSK Wins Latest Trial Over Zantac Cancer Claims

(8/5, Brendan Pierson, Reuters) ...GSK won the latest trial over claims that discontinued heartburn drug Zantac caused cancer, as a jury on Monday found that the drug was not responsible for an Illinois woman's illness, a company spokesperson said... Full

Novartis, Viatris Face New Lawsuit Over 'HeLa' Cell Misuse Claims

(8/5, Blake Brittain, Reuters) ...The estate of Henrietta Lacks accused Novartis and Viatris of unlawfully profiting from the use of the "HeLa" cells to create drugs that have been "integral to their market presence" without paying or gaining permission from her estate. A Novartis spokesperson said the company does not comment on litigation... Full

The Generics Bulletin Top 50, Part Two: Major Shifts Bring Ups And Downs For Mid-Ranked Players

(8/6, David Wallace, Generics Bulletin) ...In the second part of Generics Bulletin's Top 50, we see some companies rising up the rankings of generics and biosimilars players worldwide, passing others that are moving in the opposite direction...First off, we see Hikma leapfrogging Intas into 11th place, thanks to Hikma's 14% growth in 2023 driven by its booming injectables business as well as a rebound for generics thanks to easing pressures in the US... Global Sub. Full

Baltimore, Drug Companies Tussle in Court Over Responsibility for City's Opioid Crisis

(8/5, Madeleine O'Neill, The Baltimore Sun) ...Baltimore City Circuit Judge Lawrence Fletcher-Hill heard arguments Monday on whether he should throw out the lawsuit because, the drug companies argue, the city has not provided enough evidence to show they are responsible for the harms of the opioid crisis...The opioid companies, which include CVS, Walgreens, Johnson & Johnson, Cardinal Health, AmerisourceBergen (now known as Cencora), Teva and McKesson, say the lawsuit should be thrown out before it can reach a jury. If the city prevails, a 12-week trial is set to begin in September... Sub. Req'd

Report: Biologics Market to Grow to $1.37 Trillion by 2033

(8/5, Denise Myshko, Managed Healthcare Executive) ...The global biologics market is expected to reach $1.37 trillion by 2033, growing more than 10% from 2023, according to a recent report by Nova One Advisor. Contributing to this growth will be the approvals of novel biologics, such as gene therapy, RNA-based therapeutics, and antibody-drug conjugates... Full

Ozempic Price Draws New Call for Biden to Seize Drug Patents

(8/5, Ian Lopez, Bloomberg Law) ...Consumer advocacy group Public Citizen on Monday urged the Department of Health and Human Services to allow "any and all patents necessary" to be used by generic manufacturers to make lower-cost versions of Ozempic and Wegovy. Such generics can supply federal programs such as Medicare and "facilitate competition and make the treatments more affordable and accessible," Public Citizen said in a letter to HHS Secretary Xavier Becerra... Sub. Req'd

Indication-Specific Pricing Could Be In Spotlight At September Hearing

(8/5, Luke Zarzecki, InsideHealthPolicy) ...A spokesperson for Novo Nordisk told Inside Health Policy in a statement that Ozempic and Wegovy are different. "Although Ozempic and Wegovy both contain semaglutide, they are not the same product and are not interchangeable which is why they are not priced the same," the spokesperson said. "Ozempic and Wegovy were supported by separate and distinct clinical trial programs in different disease areas and underwent separate regulatory review processes."... Sub. Req'd

Public Citizen Urges HHS To Use Patent Authorities To Produce GLP-1 Drugs For Public Programs

8/5, Maaisha Osman, InsideHealthPolicy) ...Peter Maybarduk, director of Public Citizen's access to medicines program, tells Inside Health Policy that what they are asking is slightly different from proposals to use march-in authorities to make generic versions of expensive cancer drugs like Xtandi...Public Citizen's proposal to cut prices of the weight-loss medications would only apply to Medicare, Medicaid and other federal health programs like the Veterans Benefits Administration. Currently Medicare is prohibited from covering drugs specifically prescribed for weight-loss, but legislation moving through Congress could change that... Sub. Req'd

North Carolina Urges HHS to License Novo and Lilly Obesity Drugs as a Way to Lower Costs

(8/5, Ed Silverman, STAT Plus) ...Frustrated by the lack of access to expensive weight loss drugs, North Carolina officials are urging the Biden administration to negotiate licenses with the manufacturers so that lower-cost alternatives can be made available...In explaining the reasoning, North Carolina Treasurer Dale Folwell argued the coverage decision was forced by "corporate greed," and that the plan "repeatedly" sought to negotiate a "fair price," but that every offer was rejected, according to a July 29 letter he wrote to Department of Health and Human Services Secretary Xavier Becerra... Sub. Req'd

Merging Medical And Drug Benefits: Seeing The Whole Picture

(8/5, Suhas Gondi, Benjamin N. Rome, and William H. Shrank, Health Affairs) ...As policy makers consider a range of PBM regulations, they should be cautious about limiting integration between health insurers and PBMs. Such integration tears down silos and enables a holistic view of benefit design, which corrects misaligned incentives and facilitates efforts to manage care and spending. Preventing such integration may be a setback for patients and for the journey toward value in our health care system... Full

FDA Official Clarifies Misconceptions Around RWE in Premarket Submissions

(8/5, Jeff Craven, Regulatory Focus) ...Sponsors thinking of incorporating real-world evidence into their submissions should consider RWE as just another form of clinical evidence, according to a recent presentation from a US Food and Drug Administration official at the Orange County Regulatory Affairs Discussion Group annual conference... Full

New Survey Finds Many Coloradans Delay or Go Without Health Care Due to Cost

(8/6, John Daley, CPR News) ...High health care costs continue to hit Coloradans hard, with two in three respondents to a new survey saying they delayed or went without health care due to cost in the last 12 months. Almost three in four said they experienced an issue with health affordability in the past year...The survey found that 68 percent of respondents delayed or went without medical care because of the high cost. The is issue even more pressing for low-income respondents and those with disabilities, who reported even higher rates of delays and foregone care... Full

Severe Misconduct, Repeat Offending And Underreporting: UK/EU Codes Come Under Fire

(8/5, Neena Brizmohun, Pink Sheet) ...The UK and EU pharma industry associations have defended their respective codes of practice despite alarming study results. Meanwhile, a consultation on proposals to revise the UK code received over 3,500 comments... Sub. Req'd

Canada Expands Expedited Reimbursement Mechanism To Include All New Medicines

(8/5, Neena Brizmohun, Pink Sheet) ...The rolling reimbursement reviews that Canada's Drug Agency introduced as a pilot scheme to speed up patient access to COVID-19 products can now be used for any drug application. The move to open up the mechanism follows prompts by industry... Sub. Req'd

Indian Providers Boast Interchangeability for Insulin Biosimilars Despite Debates in the US

(8/5, Skylar Jeremias, The Center For Biosimilars) ...Indian experts believe that interchangeable biosimilar insulin glargine is as effective and safe as the reference insulin glargine and can significantly improve insulin accessibility and affordability, highlighting the need for future efforts to enhance its availability across all Indian cities, according to a study published in Cureus... Full

Pharma Industry Urges Govt for Stable Drug Pricing Policy

(8/6, Teena Thacker, The Economic Times) ...The Organisation of Pharmaceutical Producers of India (OPPI), which represents prominent multinational pharma companies, has asked the government for a "predictable" pricing policy for drugs and not to resort to Para 19 of the Drug Pricing Control Order (DPCO) that authorises the regulator to reduce prices significantly in public interest for a period as it deems fit... Full

Budget Exemptions: Spotlight Back On Cancer Drug Pricing, and Local Access Measures

(8/5, PT Jyothi Datta, The Hindu BusinessLine) ...Drugmaker AstraZeneca, beneficiary of the customs waiver on three cancer drugs this Budget, said it is working out how to pass on the benefit to patients...Responding to a businessline query on when the exemptions would translate into price benefits for patients, AZ said, "We deeply appreciate the decision and are now working on how the benefit can be passed to the patients in our country that will help expand access to innovative medicines."... Full

Drug Prices in Greece Set for Significant Hike

(8/6, Greek City News) ...The Greek National Organization for Medicines announced on Tuesday that drug prices in Greece will rise sharply this fall, with new prices for 850 medications taking effect...The Panhellenic Pharmaceutical Association revealed that the affected medications include a wide array of categories, such as serums, antibiotics, antidepressants, and anti-inflammatories. The price increases range from minor adjustments to significant hikes of up to 448%... Full

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