Tuesday, May 7, 2024

  Industry News

Biosimilars Boosts Sandoz Q1 Sales; Backs Annual Sales Outlook

(5/7, RTT News) ...Sales of Generics stood at $1.869 billion, higher than previous year's $1.868 billion. Biosimilars posted sales of $623 million, compared with $516 million in 2023. This reflects This strong double-digit growth reflects the ongoing launch of Hyrimoz high-concentration formulation, the acquisition of CIMERLI as well as continued strong demand for the company's first-ever biosimilar, Omnitrope... Full

Indian Drugmaker Lupin Misses Quarterly Profit Estimates As Costs Rise

(5/6, Kashish Tandon and Hritam Mukherjee, Reuters) ...Indian generic drugmaker Lupin reported a smaller-than-expected rise in fourth-quarter profit on Monday, as higher raw material costs more than offset strong demand for its drugs in North America and domestic markets...Indian generic drugmakers Dr. Reddy's Laboratories, Cipla and Sun Pharmaceutical Industries have benefited from strong sales and price recovery in the key U.S. market amid buoyant demand for their generic versions of the blockbuster cancer drug, Revlimid... Full

Lupin Q4 Results | Net Profit Jumps 52% to 359 Crore, Declares Dividend of 8

(5/6, Jomy Jos Pullokaran, CNBC TV 18) ...Drug maker Lupin Ltd on Monday (May 6) reported a 52.4% year-on-year jump in net profit at 359.4 crore for the fourth quarter that ended March 31, 2024...However, the company faced a notable decline in Profit Before Tax during the fourth quarter, primarily due to an impairment charge of 201.3 crore. Lupin continued to prioritise investment in Research and Development, allocating 425.5 crore, which accounted for 8.7% of sales for the quarter... Full

India's Dr Reddy's Beats Q4 Profit Estimates

(5/7, Kashish Tandon, Reuters) ...Indian generic drugmaker Dr Reddy's Laboratories reported fourth-quarter profit above expectations on Tuesday, driven by strong sales in its key U.S. and European markets...The company's U.S. sales have been boosted by persistently strong demand for Lenalidomide, a generic version of Bristol-Myers Squibb's blockbuster cancer drug Revlimid, which was launched in 2022. At the same time, Bristol Myers is facing pressure from generic competition for Revlimid , once its top-selling drug. Other generic drugmakers such as Cipla, Sun Pharma and Zydus Lifesciences have also benefitted from rising sales of their own copycat versions of Revlimid in the U.S... Full

Pfizer Takes A Hit On US Oncology Biosimilars In Q1

(5/7, David Wallace, Generics Bulletin) ...Pfizer says that pricing pressures in the US have led to its portfolio of oncology biosimilars delivering turnover 47% lower in the first quarter of 2024, as it reported its Q1 results. The firm's oncology biosimilars – primarily including Retacrit (epoetin alfa-epbx), Ruxience (rituximab-pvvr), Zirabev (bevacizumab-bvzr), Trazimera (trastuzumab-qyyp) and Nivestym (filgrastim-aafi) – together delivered turnover of $264m in the first quarter of 2024, down 36% from $412m in Q1 2023... Global Sub. Full

Second Tocilizumab Biosimilar Launches In US

(5/7, David Wallace, Generics Bulletin) ...Fresenius Kabi's April launch of its Tyenne (tocilizumab-aazg) rival to Actemra in the US has been swiftly followed by a second biosimilar in the form of Bio-Thera Solutions and Biogen's Tofidence (tocilizumab-bavi) version...Biogen's launch of Tofidence in the US comes shortly after the biosimilar was also endorsed in Europe, receiving a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use in late April. While CHMP positive opinions do not constitute formal approval, the European Commission typically acts within 67 days to convert them into pan-European marketing authorizations... Global Sub. Full

Gland Pharma Receives US FDA Nod for Immunostimulant Plerixafor

(5/7, Business Standard) ...The generic injectable-focused pharmaceutical company said that it has has received approval from the United States Food and Drug Administration for Plerixafor Injection...The company expects to launch this product through its marketing partner within FY25. According to IQVIA, the product had US sales of approximately $152 million for the twelve months ending January 2024... Full

FDA Flags 10 Observations in Another Form 483 for a Zydus Plant

(5/6, Zoey Becker, Fierce Pharma) ...Zydus Lifesciences recently received its second Form 483 reprimand from the FDA within the span of one month. In the second write-up, the regulatory agency flagged issues ranging from unqualified employees performing sample collections to improper evaluations of drug batches... Full

Amneal Agrees to $272.5M Settlement to Resolve Opioid Lawsuits

(5/6, Kevin Dunleavy, Fierce Pharma) ...Amneal revealed the settlement in its quarterly earnings presentation on Friday. Without admitting wrongdoing, the company said will make payments over the next 10 years, including $92.5 million in cash and $180 million worth of naloxone, the generic name of Emergent BioSolutions' Narcan, a nasal spray that can quickly reverse the effects of an opioid overdose and restore breathing...Last year, Teva came to an agreement with 48 states on a $4.25 billion opioid settlement. Amneal reported revenue of $659 million for the first quarter, which was an 18% increase year over year... Full

Amgen Plows Ahead With Costly, Highly Toxic Cancer Dosing Despite FDA Challenge

(5/7, Arthur Allen, KFF Health News) ...Amgen is keeping the 960-mg dosage as it conducts further tests to get final approval for the drug, spokesperson Elissa Snook said, adding that the dose showed superiority in one study. Whether medically justified or not, the heavier dosage allows the company to protect 75% of its revenue from the drug, which brought in nearly $200 million in the United States last year. And there appears to be nothing the FDA can do about it... Full

As Drug Shortages Reach Record Highs, Regulators Float Next Steps

(5/6, Kelly Bilodeau, PharmaVoice) ...The factors driving the ADHD drug shortage are unique, which underscores the primary challenge regulators face in addressing medication shortages overall — there's no single cause... Full

Biosimilars May Save Money. But Have They Lowered Out-of-Pockets?

(5/6, Tony Hagen, Managed Healthcare Executive) ...A recent study suggested biosimilars have failed to reduce patient out-of-pocket costs (OOP), but by other measures biosimilars have saved the healthcare system money and improved patient access...However, there is evidence, albeit slim, that the healthcare industry can have its cake and eat it too — higher sales of biosimilars and originator biologics plus lower OOP costs for patients... Full

  U.S. Policy & Regulatory News

Industry Groups Critique New Guidance for Medicare Drug Price Negotiations in 2027

(5/6, Nicole DeFeudis, Endpoints News) ...The Centers for Medicare & Medicaid Services proposed a number of changes to its Medicare negotiation guidance on Friday, some of which would affect how the next round of drug prices is negotiated under the Inflation Reduction Act. On Monday, industry groups PhRMA and BIO raised new concerns about the guidance... Full

Dr Inma Hernandez Discusses Potential Cost-Saving Effects of the Medicare Drug Price Negotiation Program

(5/6, Pearl Steinzor, AJMC) ...CMS's review and approval of formulary replacement of negotiated drugs will play an important role as a potential source of savings for prescription drugs, Inma Hernandez, PharmD, PhD, professor at the University of California, San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences, explained... Full

The IRA: Reducing Inflation Or Threatening Patient Access?

(5/6, Richard Hughes IV and Richard Kane, Health Affairs) ...The IRA does lower Medicare beneficiaries' costs by capping their out-of-pocket spending on retail drugs in the Part D program; however, the IRA's Medicare Drug Price Negotiation program is far more coercive than any European country system and unnecessarily threatens access to medicines for millions of Medicare and Medicaid beneficiaries... Full

A 340B Compromise at Last? Draft Federal Legislation May Provide a Clear Path Forward

(5/6, Michael French, Brenda Shafer, Richie Davis and Madison Hartman, Pharmacy Times) ...The timing of the introduction and extent to which the draft bill will be modified is unclear at this stage. Even once introduced, passage in the near future is unlikely due to ongoing Congressional gridlock exacerbated by the upcoming presidential election. However, the thoughtful nature of the draft bill and continued involvement of nearly all types of 340B stakeholders signals that the SUSTAIN Act could eventually serve as the vehicle for significant 340B Program clarifications and changes... Full

New Bill Would Pay Hospitals to Stockpile Drugs

(5/6, Michael McKauliff, Modern Healthcare) ...In a bid to curtail the ongoing problem of drug shortages, the Senate Finance Committee proposed legislation offering incentives to hospitals and other providers to stockpile certain medications...Group purchasing organizations and manufacturers such as the health system-backed Civica Rx would be able to participate. The idea is to provide struggling generic-medicine manufacturers with a more stable market and to somewhat curtail intermediaries' ability to demand prices that are too low to sustain high-quality drug makers, Senate staff said... Sub. Req'd

The World is Relying On the United States to Get Value-Based Drug Pricing Right

(5/6, Jason Shafrin, Louis Garrison, and Melanie D. Whittington, STAT) ...With the U.S. becoming increasingly sensitive to the idea that it may be overpaying for medicines, and with value and cost-effectiveness influencing drug pricing policy, all Americans — and, in fact, people around the world — have a stake in making sure that the U.S. gets it right. What does getting it right mean? We assert that taking a societal perspective for quantifying costs and benefits would produce greater value for money while continuing to provide global incentives for innovation... Full

E&C Health Subcommittee To Hold Hearing With Top FDA Officials

(5/6, Jessica Karins, InsideHealthPolicy) ...The House Energy & Commerce health subcommittee plans to hold a hearing May 22 on FDA's regulation of drugs, biologics and devices featuring the agency's lead regulators in all three areas, the committee announced Monday (May 6). The hearing will include testimony from FDA's drug center director Patrizia Cavazzoni, biologics center director Peter Marks and device center director Jeff Shuren... Sub. Req'd

Don't Stop Manufacturing Because of An Inspection, FDA's Cavazzoni Says

(5/6, Sarah Karlin-Smith, Pink Sheet) ...The US Food and Drug Administration is "strongly encouraging" drug manufacturers not to unilaterally stop manufacturing during or because of an agency inspection to prevent unnecessary essential medicine shortages. Instead, facilities should call the agency's drug shortage surveillance team "immediately," said Center for Drug Evaluation and Research Director Patrizia Cavazzoni... Sub. Req'd

Remodeling REMS: FDA Kicks Off Guidance Series With Draft On New Framework

(5/6, Zachary Brennan, Endpoints News) ...In the first of what's expected to be a series of REMS-related advice for the industry, the FDA on Monday unveiled new draft guidance on how to improve the safety programs often attached to higher-risk drugs... Full

FDA Unveils Draft Guidance On REMS Logic Models

(5/6, Jeff Craven, Regulatory Focus) ...FDA described a REMS logic model as a framework recommended by the agency that is a "systematic, structured approach to the design, implementation, and evaluation of a REMS" with a goal of having the applicants' goals, objectives, and strategies line up with intended outcomes...They noted the draft guidance does not focus on the relationship between REMS or risk management and the benefit-risk assessment for a drug, nor does it focus on when the use of a REMS is necessary to determine when the benefits of a drug outweigh its risks... Full

FDA: ‘Model Master Files' Could Support Generic Drug Development

(5/6, Jessica Karins, InsideHealthPolicy) ...FDA is working to create a new "model master file" approach that would allow sharing and reuse of models used in drug development in the same vein as drug master files, and officials say the tools could be especially useful in the development and approval of generic drugs. Agency officials touted the model master file framework as an equivalent to the drug master file, which would use a standing regulatory mechanism to similarly allow for generic drug companies to benefit from the use of existing research while mitigating the risks of information-sharing... Sub. Req'd

  International News

Can EU Wean Itself Off Essential Drugs from China, India?

(5/7, Insa Wrede, Deutsche Welle) ...Europe's huge shortage of medical masks during the coronavirus pandemic has laid bare the continent's vulnerability in ensuring a steady supply of basic medicinal products. In 2020, the EU Parliament stated in a report that public health could be a "geopolitical weapon that can bring down an entire continent." The EU has since made attempts to identify the types of medicines it can only source from outside the bloc, notably from China. Holzgrabe said this effort now needs to be intensified with a database on which company actually produces what and who provides the precursor chemicals for drug production... Full

Bratislava Hesitates On Pharma Package, Concerns Voiced On RDP's Unpredictability

(5/6, Filip Ác, Euractiv) ...Euractiv discussed the Pharma Package with Peter Potúcek, former director of the State Institute for Drug Control and member of the management board at EMA, currently a senior partner at PHC Project HealthCare think-tank. "From my perspective, the critical aspect of the Commission's proposal is the unpredictability of the proposed RDP scheme. The application of an additional two years of market protection will only be possible upon the introduction of the drug to the market in all member states," said Potúcek... Full

Belgian Innovative Pharma Sector Urges Government to Prioritise Competitiveness

(5/6, Nicole Verbeeck, Euractiv) ...The Belgian innovative pharmaceutical industry continues to grow, but competitiveness dynamics and EU pharma package revisions are causing uncertainty. Euractiv spoke in depth with Caroline Ven, CEO of pharma.be, about the sector's concerns. Despite significant growth in added value, employment, and investments, and with Belgian companies injecting €15 million daily into research and development – totalling €5.7 billion, a remarkable 58.4% increase over the past five years – Ven sounds a cautionary note, citing the latest Pharma Figures... Full

Supply Chain Derisking: The Case For US-India Partnering Amid China Clout

(5/7, Anju Ghangurde, Generics Bulletin) ...With just 14% of active pharmaceutical ingredients estimated to be made in the US and China's overall dominance in the space, a new study points to the pressing need for the US to address bottlenecks in the supply chain and proposes a string of approaches to partner with India in its de-risking efforts. The COVID-19 pandemic highlighted the risks of concentrated supply chains and the impact these can have on medicines security across countries, with ongoing geopolitical tensions and wars only further complicating present-day dynamics... Global Sub. Full

Indian Pharmaceutical Leaders Urge U.S.-India Partnership 'Affordable Medicine Partnership'

(5/7, ANI) ...The Indian Pharmaceutical Alliance - comprising 23 leading Indian research-based generic pharmaceutical companies - convened today at the DAR Museum in Washington DC to urge a U.S.-India trade partnership to reduce reliance on foreign sources for both nation's pharmaceutical supply chain and achieve affordable medicine resilience... Full

Amid Heightened Global Concerns Over India-Made Drugs, Govt Plans An Exports Revamp

(5/7, Priyanka Sharma, Mint) ...India's drug regulator is gradually overhauling the approvals process for pharmaceutical exports following concerns by global authorities over the quality and safety of medicines shipped from the country. The latest decision involves upgrading India's Certificate of the Pharmaceutical Product to be at par with the World Health Organization's good manufacturing practices certification, according to two officials familiar with the developments... Full

The Absence of a Quality Mindset

(5/7, Prosenjit Datta, Business Standard) ...Every country that became a manufacturing power did so by raising the quality bar of products made by them, and by ensuring that domestic customers were not shortchanged in terms of quality. Indian policymakers need to understand this. Equally, the corporate sector needs to understand that without adopting the quality mindset, they can never aspire to be globally competitive... Sub. Req'd

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