Monday, December 2, 2024

Where Are They Now? Teva Pharmaceuticals

(11/29, Ben Comer, Life Science Leader) ...Biosimilars play and important part in pivot to growth and are a "main component" of the strategy, says Thomas Rainey, SVP, U.S. biosimilars, at Teva. "When you look at Teva's overall commitment to biosimilars, we have 15 assets in the pipeline which cover around 70% of the top 20 drugs coming off patent in the next few years." Teva currently markets three biosimilars in the U.S. and plans to launch a fourth — Selarsdi, a biosimilar version of J&J's Stelara — in February 2025. Branded biologic drugs are expensive, and Rainey says Teva's opportunity to reduce costs for patients with generics and biosimilars "is important to us."... Full

Shortage of Methylphenidate Hydrochloride Modified-Release Tablets

(11/28, Australian Government Department of Health and Aged Care) ...We have been notified about current and anticipated shortages of Concerta and Methylphenidate-Teva XR modified-release methylphenidate hydrochloride tablet products. These medicines are used to treat attention deficit hyperactivity disorder (ADHD). We acknowledge the concerns and difficulties caused by such shortages, especially due to the specific requirements for prescribing and dispensing methylphenidate hydrochloride. We hope this early notification will give patients and prescribers the opportunity to plan ahead... Full

Methylphenidate Extended Release Oral Presentations

(11/27, ASHP) ...Teva has methylphenidate 18 mg, 27 mg, 36 mg, and 54 mg extended-release tablets on intermittent back order and the company is releasing supplies as they become available. The 20 mg, 30 mg, and 40 mg extended-release (LA) capsules are temporarily unavailable. The 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and 60 mg extended-release (XR) capsules are on intermittent back order and the company is releasing supplies as they become available... Full

European Biosimilars Revenues Pull Celltrion Through In Q3

(11/28, Urte Fultinaviciute, Generics Bulletin) ...The star of the quarter was subcutaneous infliximab biosimilar, marketed as Remsima SC in the region. It recorded "the highest quarterly sales with continuous sales growth in entire Europe beyond" the five major European markets, where it captured 24% of the market share. Both subcutaneous and intravenous Remsima combined achieved 76% of the market in the EU5, accounting for 88% of the market share in the UK, 77.3% in France, 74.7% in Spain, 71% in Germany, and 50.6% in Italy... Global Sub. Full

Celltrion to Break Ground On CDMO Plant in 2025: Chairman Seo

(11/28, Jeong Min Nam and Dae-Kyu Ahn, The Korea Economic Daily) ...South Korea's leading biosimilar developer Celltrion Inc. will break ground on its first contract development and manufacturing organization (CDMO) plant in Korea next year, said its chairman about three months after the company unveiled a plan to venture into the CDMO market... Full

Celltrion Files for Phase 3 Trial of New Cancer Biosimilar in US

(12/2, Hwang Joo-young, The Korea Herald) ...South Korean biopharmaceutical firm Celltrion said Monday it has submitted an investigational new drug application to the US Food and Drug Administration for a Phase 3 clinical trial of CT-P44, its new biosimilar candidate referencing Darzalex... Full

Viatris Says Goodbye To Another Generics Asset

(11/29, Dave Wallace, Generics Bulletin) ...Viatris has struck a deal to offload another off-patent asset, agreeing to divest its US unit-dose packaging business to Safecor Health. The transaction is expected to be finalized in the first half of 2025... Global Sub. Full

Hikma Discusses Quality Vs Quantity Approach At Jefferies

(11/29, Adam Zamecnik, Generics Bulletin) ...Attended by Hikma's chief executive officer Riad Mishlawi and the company's chief financial officer Khalid Nabilsi, the Q&A session provided an overview of the pharmaceutical firm's latest efforts and strategic priorities while also reflecting on global developments. Currently, the firm introduces between 10 to 15 smaller products a year into the market, noted Mishlawi. However, the company is changing its strategy by producing fewer products with more impact... Global Sub. Full

Bayer Patent Cliff Is Actually More of a Dent, Pharma Head Says

(11/29, Sonja Wind, Bloomberg) ..."The patent cliff is more of a dent than a cliff," Stefan Oelrich said in an interview Thursday. "I believe that this will be proven in the course of the year." The German group is racing to offset a decline in revenue as blood thinner Xarelto and eye medicine Eylea lose patent protection. This will open the company up to competition from cheaper generic versions of the medicines... Full

Biocon Biologics Receives US FDA Nod For Yesintek, A Biosimilar To J&J's Stelara Vikas Srivastava

(12/1, Vikas Srivastava, NDTV Profit) ...Biocon Biologics Ltd. has received US Food and Drug Administration approval for Yesintek, a biosimilar for Johnson & Johnson's reference product, Stelara. This approval marks a major breakthrough for Biocon Biologics, a fully integrated global biosimilars company and subsidiary of Biocon Ltd... Full

Dr Reddy's Launches World's 1st Immuno-Onco Drug for Nasopharyngeal Cancer in India

(11/28, Swati Bharadwaj, The Times Of India) ...Pharma major Dr Reddy's Laboratories Ltd on Thursday said it has rolled out Toripalimab, the world's first and only immuno-oncology drug approved for the treatment of nasopharyngeal carcinoma, which is a rare form of head and neck cancer, in the Indian market... Full

Abingworth 'Will Launch $1.5Bn Fund for Co-Developed Drugs'

(12/2, Phil Taylor, PharmaPhorum) ...The Carlyle-backed investor is hoping to provide backing for up to eight late-stage clinical trials in the pioneering financing model, according to the Financial Times, which cited people familiar with the matter. If confirmed, the new fund would represent an upscaling of an unusual investment approach that Abingworth has already started implementing through agreements earlier this year with Gilead Sciences and Teva... Full

European Pharma's Growth Prescription: Pivot to US

(11/28, Aimee Donnellan, Reuters) ...The biggest threat for European pharmaceutical groups currently comes from the United States. President-elect Donald Trump and his proposed Health Secretary Robert F. Kennedy Jr amount to a toxic cocktail of "America First" nationalism and anti-drugmaker sentiment, which is doubly bad from the perspective of $480 billion Novo Nordisk, $230 billion Roche and the rest. Ironically, the best way to mitigate these risks is to get closer to the source of the problem. More U.S. manufacturing investments, and even M&A, could help... Full

Doctors Hail First Breakthrough in Asthma and COPD Treatment in 50 Years

(11/27, Andrew Gregory, The Guardian) ...Doctors are hailing a new way to treat serious asthma and chronic obstructive pulmonary disease attacks that marks the first breakthrough for 50 years and could be a "gamechanger" for patients. A trial found offering patients an injection was more effective than the current care of steroid tablets, and cuts the need for further treatment by 30%. The results, published in the Lancet Respiratory Medicine journal, could be transformative for millions of people with asthma and COPD around the world... Full

US ADHD Stimulant Shortage Highlights Growing Challenges in Adult Treatment

(11/27, Giuliana Grossi, AJMC) ...The stimulant shortage reveals critical gaps in ADHD treatment, especially for adults, with rising diagnoses and limited clinical guidance complicating care. Despite increased production quotas, DEA-imposed caps restrict supply, failing to meet rising demand for ADHD medications. Critics argue DEA quotas are overly restrictive, hindering access for patients with ADHD and exacerbating the shortage. Calls for DEA reform emphasize prioritizing patient needs over concerns about misuse, aiming to resolve the ongoing medication shortage... Full

What's Next? Five Things To Look Out For In December

(12/1, Dean Rudge, Generics Bulletin) ...Viatris this month plans to meet with the US Food and Drug Administration after its Mapi Pharma-partnered proposed once-monthly glatiramer acetate ‘GA Depot' product, a follow-on to Teva's Copaxone treatment for relapsing forms of multiple sclerosis, was knocked back by a complete response letter...Hikma is set to bolster its generic offerings in the US this month by launching a generic version of Novo Nordisk's GLP-1 agonist Victoza (liraglutide), with the expiry of Teva's six-month exclusivity period... Global Sub. Full

A Generation of Drug-Addiction Survivors Is Entering Old Age

(12/1, Julie Wernau, The Wall Street Journal) ...America's drug crisis has many survivors. Jerry Schlesinger, 72, is among the longest tenured...His is a living history of a drug crisis that has left millions of people in poor health and searching for purpose. The most senior are entering old age. Their struggles show how the damage wrought by addiction will linger long after the death toll drops... Full

Big Pharma Pushes Trump Team to Ease Medicare Drug Price Negotiation Rules

(11/27, Michael Erman, Patrick Wingrove, Maggie Fick, Reuters) ...Seven lobbyists and executives who work with top pharmaceutical and biotech companies told Reuters they are pushing to delay the timeline under which medications become eligible for price negotiations by four years for small molecule drugs, which are primarily pills and account for most medicines. Two sources said the industry is already speaking directly with members of the Trump transition team... Full

The Good, The Bad, And The Uncertain: Trump's Second Administration And The Rx Industry

(11/29, Nielsen Hobbs, Pink Sheet) ...The pharma industry arguably suffered none of the possible downside risks during the first Trump Administration, but its relationship with Biden could not have been much worse. And while sponsors may hope a Trump return could improve their fortunes, having Robert F. Kennedy Jr. supervising the FDA is likely not the prescription they prefer... Global Sub. Full

Drug Companies Face Hostility as They Hope for Allies Among Trump's Health Picks

(11/27, Rebecca Robbins, Christina Jewett, Kate Kelly, The New York Times) ...Drug company executives had hoped that a second Trump administration would be staffed by friendly health policy officials who would reduce regulation and help their industry boom. But some of President-elect Donald Trump's proposed nominees are instead alarming drug makers, according to interviews with people in the industry... Sub. Req’d

Generics and Biosimilars: A Lifeline for Patient Affordability

(11/28, John Murphy III, The Atlantic) ...Recently, at The Atlantic's "The Next Frontier for Accessible Medicines" event, which convened health-care leaders and lawmakers, [AAM CEO John Murphy III] led an underwriter-supported session to celebrate the 40th anniversary of the Hatch-Waxman Act—a law enacted in 1984 that significantly boosted the availability of lower-cost generic drugs—and discuss the future of prescription drug policy. The Act, which laid the groundwork for today's generics market, remains a cornerstone of efforts to expand availability of affordable medicines. We spoke with Murphy about the current state of the healthcare system and the pivotal role policy will play in shaping a future where affordable medicines aren't the exception, but the norm... Full

Disappointing Vote Could Mean Higher Prices for Prescription Drugs

(11/27, Patricia Kelmar, PIRG) ...In a disappointing blow to efforts to reduce the high cost of drugs, the Senate Judiciary Committee narrowly voted out of committee the PREVAIL Act. For months PIRG, our members, and a strong coalition of health care and patient groups have been urging Senators on the committee to oppose the bill. But on Thursday November 21, 2024, 11 Senators voted YES, instead of NO... Full

Q&A: A Closer Look at the Current State of Biosimilars in the Drug Market

(11/28, Brian Nowosielski, Drug Topics) ..."Over time, we have seen that the price of biosimilars have come down, and that does end up saving patients money because these are more complicated products," said Steve Callahan, Senior Director of Advisory & Insights at MMIT. He recently joined Drug Topics to discuss biosimilars. From real-world data that his company has collected to inform their customers to the market insights that support the dispensing of biosimilars, he went into depth on one of the pharmaceutical market's newest products... Full

Biosimilar Approval and Uptake Impacted by Global Regulatory Frameworks

(11/28, Cameron Santoro, The Center For Biosimilars) ...Policies promoting product-specific guidance, extrapolation, shorter exclusivity periods, and substitution are linked to greater biosimilar approval and uptake, potentially increasing access to affordable biologics globally, according to an evaluation of international biosimilar policies published in the Journal of Law and the Biosciences... Full

Despite Achievements, Barriers That Discourage Biosimilar Use Remain

(12/2, Wayne Winegarden, Pacific Research Institute) ...Despite the savings biosimilars have already enabled, there are barriers to further progress. First, the price controls from the Inflation Reduction Act (IRA) disincentivize biosimilar development. Second, the convoluted pricing system discourages greater use of lower cost alternatives. How the payment system disincentivizes their use varies depending on whether the medicine is administered in a clinical setting or taken at home by patients. While not addressed here, there are also psychological concerns and insufficient professional education regarding the safety and efficacy of biosimilars as documented in a 2024 JAMA study that also need to be addressed... Full

Q&A: The Future of Biosimilar Pricing at the Pharmacy Counter

(11/30, Brian Nowosielski, Drug Topics) ...Steve Callahan, Senior Director of Advisory & Insights at MMIT, discussed out-of-pocket costs and the impact biosimilars are predicted to have for patients in the future... Full

Trump Picks Florida Sheriff to Lead DEA

(12/2, Adriel Bettelheim, Axios) ...If confirmed, Hillsborough County Sheriff Chad Chronister would be the point person for containing a highly addictive man-made opioid that's a leading cause of death and frequently disguised in unexpected forms...Chronister, if confirmed, will have to settle the question of whether to continue making controlled substances available without an in-person doctor's visit. Behavioral health providers say access to drugs like Adderall and other amphetamines like Vyvanse used for attention-deficit/hyperactivity disorder would be even tighter if old limits requiring an in-person doctor's visit were restored... Full

Trump 2.0: India Pharma On A Good Wicket?

(11/29, Anju Ghangurde, Pink Sheet) ...The optimism is being driven by the incoming US administration's alignment, in general, with addressing healthcare costs and access, a hawkish China stance and a seeming penchant to dilute the policy thrust of its predecessors - though with US President-elect Donald Trump, you can never perhaps be sure of what's in store. A senior Indian industry expert said that the key priorities for any government around the world include affordable healthcare as well as health security, more so in this case with an eye on China... Global Sub. Full

Former Trump FDA Chief is Seeking to Undermine RFK Jr.'s Senate Confirmation

(11/29, Rachel Cohrs Zhang, STAT) ...Scott Gottlieb, who served as Food and Drug Administration commissioner in the first Trump administration, is raising concerns with Senate Republicans about the president-elect's selection of Robert F. Kennedy Jr. to lead the Department of Health and Human Services, he said in a television appearance Friday... Full

FDA Generic Drug Science and Research Priorities for 2025

(11/28, The Pharma Letter) ...The FY 2025 GDUFA science and research priorities encompass scientific challenges that the generic industry and the FDA's Generic Drug Program have identified as opportunities to advance the science behind generic drugs. Determining priorities is particularly important for complex products to ensure the program continues its focus on development of innovative methodologies and efficient tools to establish the bioequivalence and quality of generic alternatives... Sub. Req’d

FDA Provides Update On PSG Plans As 60 More Guidances Issued

(11/28, Dave Wallace, Generics Bulletin) ...Updating its dedicated PSGs web page, the FDA provided details of 69 new PSGs and 33 planned revised PSGs on the horizon in the coming year. Meanwhile, a further 42 PSGs are set to be revised to align with guideline M13A on bioequivalence for immediate-release solid oral dosage forms published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use... Global Sub. Full

B.C. Can Sue Opioid Providers for Health-Care Costs On Behalf of Other Governments, Canada's Top Court Rules

(11/29, Yasmine Ghania, CBC News) ...Canada's top court has ruled that British Columbia can bring forward a class-action lawsuit against pharmaceutical manufacturers, distributors and retailers for harms caused by opioids on behalf of other provinces, territories and the federal government. Supreme Court of Canada dismisses appeal by pharmaceutical manufacturers, distributors and retailers... Full

BGMA Backs UK Call For Shortages Strategy

(11/28, Dave Wallace, Generics Bulletin) ...A report on UK medicine shortages published by the Royal Pharmaceutical Society calling for a national strategy to manage the issue has been lauded by the British Generic Manufacturers Association as "comprehensive and welcome". The RPS report – titled Medicines Shortages: Solutions For Empty Shelves – comes shortly after the BGMA off-patent industry association last month put forward a raft of policy proposals that it said could provide solutions to shortages facing the UK... Global Sub. Full

European Shortages Monitoring Platform Enables Better Monitoring of Shortages in the EU

(11/28, European Medicines Agency) ...The European Shortages Monitoring Platform (ESMP) has gone live with a core set of functionalities. Using this first version of the ESMP, marketing authorisation holders (MAHs) can now submit data to routinely report shortages of centrally authorised medicines. This marks the start of a transition period that will end on February 2, 2025, when the use of the platform becomes mandatory... Full

Europe's Pharma Sector Falling Behind US and China, Competitiveness Drive is Urgent, Vital

(11/27, Paulina Mozolewska, Euractiv) ...Despite a decade of gradual growth, new data reveals how the United States, despite facing increasing competition from China, is outpacing Europe in research and development (R&D) spending. Europe's pharma sector is alarmed and calling on the EU to shift gears on competitiveness and investment. "This is another report that should be a wake-up call for policymakers when it comes to Europe's competitiveness," Michal Byliniak, General Director of INFARMA, told Euractiv... Full

China Race On For New Wave Of Novel Drugs

(11/28, Dexter Jie Yan, Pink Sheet) ...A new China government R&D support program will focus on four major chronic disease areas with high prevalence in China – cardiovascular, respiratory and metabolic diseases and malignant tumors. In 2023 and 2024, a total of CNY3.3bn ($449m) in central government funding have been earmarked for spending on two batches of drug development programs. The new campaign will succeed the previous Major Novel Drug Creation Project, which ran from 2008 and 2020... Global Sub. Full

Strengthening Drug Security Through a Resilient and Affordable Pharmaceutical Supply Chain

(11/30, Saransh Chaudhary, Express Pharma) ...Saransh Chaudhary, President, Global Critical Care, Venus Remedies, and CEO, Venus Medicine Research Centre explains strategies to prevent pharma supply chain risks, ensure a constant supply of essential generics... Full

Affordable Medicine, Smarter Insurance: The Blueprint for Lowering India's Healthcare Costs

(11/30, Susheel Agarwal, Express Healthcare) ...The affordability of generic drugs has long been touted as a solution to this crisis. Yet, adoption within India remains alarmingly low compared to global benchmarks. For instance, generic drugs account for only 55 per cent of total prescriptions in India, while in countries like the US, that figure exceeds 90 per cent, saving billions annually. What's holding us back? This is where health insurance can step in—not just as a safety net but as a catalyst for transformation. By integrating the promotion of generic drugs into insurance frameworks, India can address the dual challenge of affordability and accessibility... Full

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