Tuesday, May 28, 2024

Eye On Pharma: Simlandi US Launch; Ranibizumab Partnership; Expanded Access for Adalimumab Biosimilars

(5/27, Skylar Jeremias, The Center For Biosimilars) ...Teva, focusing on market access, highlighted the cost-saving potential of biosimilars and aims to launch 6 more by 2027. Alvotech, responsible for development and manufacturing of Simlandi, emphasized the importance of cost-effective biosimilars in reducing health care costs...Simlandi is the first product from this collaboration, followed by Selarsdi (ustekinumab-aekn) approved by the FDA in April 2024... Full

The Top 20 Drugs by Worldwide Sales in 2023

(5/28, Zoey Becker, Angus Liu, Kevin Dunleavy, Fraiser Kansteiner, Eric Sagonowsky, Fierce Pharma) ...While Johnson & Johnson's antibody star Stelara continued to rake in megablockbuster sales last year, 2023 marked something of a last hurrah for the immunology medicine. That's because J&J spent much of the year inking patent settlements with biosimilar challengers Amgen, Samsung Bioepis, Sandoz, Teva and Alvotech, in turn clearing the way for biologic copycats of its lucrative drug to hit the scene in the U.S. starting in early 2025...Biosimilars from Teva, Sandoz, Celltrion and Fresenius Kabi are expected to hit the scene in the months following Amgen's launch... Full

Indian Pharma Companies May Cash in On US Drug Shortages

(5/28, Sohini Das, Business Standard) ...Even as US drug shortages hit a decade-high of 323 drugs across 22 therapies in the January-March quarter of calendar year 2024 (CY24), analysts feel this presents an opportunity for Indian pharmaceutical exporters...Players like Teva Pharmaceutical Industries halted production of around two dozen critical injectables in mid-2022 at their California facility. "A broken US pharma supply chain has made it difficult for generic drug manufacturers to make profits in a commoditised oral-solids portfolio and stay in the business. As a consequence, few US-based drug manufacturers have shut down the business," said IIFL... Full

Drug Shortage in the US to Prove Beneficial for Indian Pharma Companies

(5/28, Ind-Ra, Express Pharma) ...India Ratings and Research (Ind-Ra) expects US-focused pharma companies to sustain their revenue improvement trend in FY25 on account of heightened drug shortages in the US market. This will not only provide potential for volume growth, but also limit price erosion to single digits over the next 12-18 months, leading to improved returns. Also, given the limited original abbreviated new drug application filings and delays in approvals provided by the USFDA, the drug shortage in the US provides an opportunity for Indian players with necessary approvals to gain market share in a competitive-but-attractive market... Full

Indian Drugmakers to See FY25 Revenue Boost in Key US Market, Says India Ratings and Research

(5/27, Rishika Sadam, Reuters) ...Indian drugmakers, which have the U.S. market as a key segment, will sustain their revenue improvement in fiscal 2025 due to drug shortages in the United States, Mumbai-based India Ratings and Research said on Monday. India is a hub of bulk generic drug manufacturing and drugmakers including Dr Reddy's, Cipla, Sun Pharma derive a significant share of revenue from both the U.S. and Europe...Indian companies could likely fill the gap by expanding supply chains and increasing participation across therapeutic categories, it said... Full

Amphastar Boosted By Baqsimi And Shortages

(5/28, Adam Zamecnik, Generics Bulletin) ...The American pharma reported first quarter results that highlighted the ongoing impact of shortages affecting Amphastar's competitors, alongside the first sales of Baqsimi...Capitalizing on shortages affecting Amphastar's competitors is an ongoing part of the company's business strategy...Outside of biosimilars, the firm has just received FDA approval for its AMP-008 generic version of Teva's ProAir (albuterol) inhaler. Amphastar CEO and president Jack Zhang said the approval of the firm's first generic inhalation product "reflects both our technological and manufacturing ability" while providing "a solid foundation for future growth in developing our other generic inhalation products, highlighting our expertise in developing complex products."... Global Sub. Full

Gedeon Richter's Q1 Hit By Weak Ruble But Expects More M&A In Q2

(5/24, Urte Fultinaviciute, Generics Bulletin) ..."A solid start of the year" is how Gedeon Richter described its performance during the first quarter of 2024. The Hungarian firm reported HUF200bn ($564m) in pharma revenues, which was a 12.6% year-on-year increase, with the CEO Gábor Orbán calling it a "milestone for one-quarter revenues."... Global Sub. Full

Glenmark Pharma Unveils Growth Plans; Shares Rise 8%

(5/27, The Hindu) ..."This past year has been a period of significant transition and transformation for Glenmark. We successfully divested a majority stake in Glenmark Life Sciences, concluding the year in a strong net cash positive position. Our branded markets continued to deliver robust growth, particularly in Europe and other key international markets. While we encountered some headwinds in our US business, we remain optimistic about ability to regain our growth trajectory in the coming year." said Glenn Saldanha, Glenmark Pharma's Chairman and Managing Director... Full

Aim is to Be Among Top Three Biosimilars Players Globally: Biocon Biologics CEO Shreehas Tambe

(5/27, Financial Express) ...Biocon's biosimilars business crossed the $1 billion revenue-mark in FY24. In an interview with the FE, Biocon Biologics CEO and MD Shreehas Tambe discussed how the company was able to maintain its revenue growth momentum in a year that saw it successfully implement an accelerated and complex integration of the business acquired from Viatris. Excerpts... Full

Fresenius Announces FDA Acceptance for Review of Denosumab Biosimilar Application

(5/27, Fresenius) ...Fresenius, via its Operating Company Fresenius Kabi, announced today that the U.S. Food and Drug Administration has accepted for review the company's Biologics License Application for its biosimilar candidate of Prolia® (denosumab) and Xgeva® (denosumab)... Full

Samsung Bioepis Tops in Soliris Biosimilar Market in Europe

(5/27, Jeong Min Nam, The Korea Economic Daily) ...The biopharmaceutical development unit under South Korea's Samsung Group unveiled at the 61st ERA Congress held in Stockholm between May 23 and 26 that its PNH treatment Epysqli commands the largest share of more than 50% in the Soliris biosimilar market in Europe less than one year after its launch...[Samsung Bioepis' Head of Europe Antonio Rito] said Samsung Bioepis aims to win 95% of PNH patients and 80% of aHUS patients who are prescribed with Soliris this year so it can become the No. 1 brand in the global rare disease treatment market... Full

Bio-Thera and STADA Reach Exclusive Agreement for BAT2506, A Proposed Golimumab Biosimilar, in the EU and UK

(5/28, Bio-Thera) ...Bio-Thera Solutions, a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, and global specialty, generic and consumer healthcare medicines company STADA Arzneimittel AG have reached an exclusive commercialization and license agreement for BAT2506, a biosimilar candidate to Simponi® (golimumab)... Full

Dr. Reddy's and Novartis Sign Distribution Agreement for Anti-Diabetes Products

(5/27, Pharmaceutical Technology) ...Dr. Reddy's Laboratories' Russian subsidiary has signed an agreement with Novartis Pharma to carry out the sale and distribution of the anti-diabetes products, Galvus and Galvus Met. The distribution agreement outlines that Dr. Reddy's Laboratories LLC, Russia (DRL) will distribute these products within the retail sector and engage with healthcare specialists through its own sales force and pharmacy chain management... Full

Fosun To Fully Acquire Henlius In Go-Global Push?

(5/28, Brian Yang, Generics Bulletin) ...Parent Fosun and biosimilars arm Henlius halt share trading on the same day, sparking speculation of a buy-out deal that would assist the Chinese firms' globalization push. If the swirling speculation proves to be true, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. may become the second large Chinese biopharma group to quickly bolster its commercial portfolio and accelerate overseas expansion through a major corporate transaction... Global Sub. Full

Eli Lilly Invests Additional $5.3B for Production of Diabetes, Obesity Drugs in Indiana

(5/24, Kevin Dunleavy, Fierce Pharma) ...On Friday, the Indianapolis-based drugmaker revealed its plan to take a giant leap in the race, as it will invest an additional $5.3 billion to build a massive manufacturing complex, 30 miles away in Lebanon, Indiana. The expenditure will boost production of active pharmaceutical ingredient for its injected tirzepatide products Mounjaro, for type 2 diabetes, and Zepbound, for obesity, Lilly said... Full

Weight-Loss Drug Forecasts Jump to $150 Billion As Supply Grows

(5/28, Deena Beasley, Reuters) ...As millions seek access to weight-loss drugs from Novo Nordisk and Eli Lilly, increasing supplies, possible wider usage and a growing number of would-be rivals are leading some experts to raise annual global sales forecasts for the treatments to about $150 billion by the early 2030s..."It is very unusual to have a medicine that is capturing the imagination of millions of people," said Michael Kleinrock, senior research director at healthcare analytics firm IQVIA Institute for Data Science. Most insurers do not cover the new therapies with low co-payments, but an unprecedented percentage of people are paying themselves or with coupons from drug manufacturers, he said... Full

Weight-Loss Powerhouse Saxenda Among Dozens Of New FDA Guidance Docs

(5/24, Dean Rudge, Generics Bulletin) ...Novo Nordisk's self-injectable GLP-1 receptor agonist Saxenda (liraglutide), the heavily advertised and extensively used treatment for obesity, is among 32 new and revised product specific guidance documents published by the US Food and Drug Administration...Also included in the FDA's latest new guidance documents are two inhalers: Acorda Therapeutics' Inbrija (levodopa) for OFF episodes in adults with Parkinson's treated with regular carbidopa/levodopa medicine; and Viatris' Tobi (tobramycin) Podhaler for cystic fibrosis patients whose lungs contain the bacteria Pseudomonas aeruginosa... Global Sub. Full

Aurobindo Pharma Gets Official Action Indicated Status from USFDA; Shares Trade Lower

(5/27, Money Control) ...The United States Food and Drug Administration had conducted an inspection at Unit III, a formulation manufacturing facility, of Eugia Pharma Specialities Ltd., a wholly owned subsidiary of the company, situated at Pashamylaram, Patancheru Mandal, Sangareddy District, Telangana, from 22nd January to 2nd February 2024. Subsequently, the USFDA has determined the inspection classification status of this facility as ‘Official Action Indicated'... Full

Insights From Cencora's Lakesha Farmer: Innovative Biosimilar Adoption Strategies

(5/26, Skylar Jeremias and Ashley Gallagher, The Center For Biosimilars) ...Lakesha Farmer from Cencora discusses innovative pricing and reimbursement models incentivizing biosimilar adoption and competitiveness, including dual pricing strategies and the Mark Cuban Cost Plus Program, while highlighting potential impacts on patient assistance programs... Full

Steal This Idea: How This Health Plan Got Buy-In On Biosimilars

(5/26, Rylee Wilson, Becker's Payer Issues) ...Biosimilar versions of adalimumab were introduced in January of 2023, and approaches to the drug from insurers and pharmaceutical benefit managers have varied. In April, CVS Caremark removed brand-name Humira from its formulary. Optum, another large PBM, covers biosimilars and brand-name Humira on the same tier in its formulary. Champaign, Ill.-based Health Alliance plan has 250,000 members in Illinois, Iowa, Indiana, Ohio and Washington. Leaders at the plan sat down with Becker's to discuss how they developed their biosimilar strategy... Full

Study Finds Guidance Is Needed for Health Technology Assessments of Biosimilars

(5/27, Ashley Gallagher, Pharmacy Times) ...Clear guidance on how and when to conduct health technology assessments (HTAs) of biosimilars is needed due to differences in perception of HTAs' role in the biosimilar space for authorities deciding pricing and reimbursement, according to a study published in Value in Health. HTAs are used for the safe and cost-effective adoption of medications, which is well established for new biologics but has challenges when applied to biosimilars... Full

Smaller PBMs Wary Of Optum Rx's Plan For Guarantee-Based Pricing

(5/24, Gabrielle Wanneh, InsideHealthPolicy) ...Joe Shields, managing director and founder of the small PBM coalition Transparency-Rx, says this announcement should raise warning signs from drug market and government stakeholders, not applause...Shields says it's understandable that Optum Rx is attempting to make changes to shift public perception in the wake of the ChangeHealth cyberattack and the increased scrutiny of PBMs and group purchasing organization practices from the Federal Trade Commission and Department of Justice... Sub. Req'd

Insulin Cap Talk Ignores Market-Based Success Story

(5/24, Pat Toomey, RealClearPolicy) ...The most effective way to keep making insulin more affordable for all Americans who need this life-saving medicine is to let the market keep making insulin more affordable. By leveraging competition and innovating to meet a demand from their customers, PBMs are successfully delivering on this trend, and showing the value of unimpeded market forces in healthcare. Policymakers should pay attention... Full

Experts, Lawmakers Express Support for Select Drug Patent Reforms

(5/24, Joanne S. Eglovtich, Regulatory Focus) ...Senators on both sides of the aisle agreed that patent reform is needed to stop pharmaceutical companies from extending patents on minor modifications to products and linked this problem to high prescription drug prices. Witnesses at a Senate Judiciary Committee hearing on Tuesday suggested one way to address patent reform is to have greater coordination between the Food and Drug Administration and the US Patent and Trade Office on patents listed in the Orange Book... Full

AAM Backs FDA's Proposal For Skinny-Label Safe Harbors

(5/28, Urte Fultinaviciute, Generics Bulletin) ..."Despite this well-established practice, a recent decision from the US Court of Appeals for the Federal Circuit threatens to undermine Hatch-Waxman's carve-out process," said AAM, highlighting the recent legal battle between GSK and Teva...AAM highlighted that this decision "threatens to nullify the longstanding carve-out mechanism that allows generic manufacturers to quickly get affordable, FDA-approved medicines to patients" and the uncertainty may discourage manufacturers from attempting early launch of generic drugs and biosimilars. However, the organization argued that the FDA's proposal is reasonable and targeted to correct the "mistaken" decision... Global Sub. Full

The Checkup: ‘Junk Patents' by Big Pharma Lead to Soaring Drugs Prices, FTC Says

(5/24, Elizabeth Gabriel, WFYI) ...The cost of drugs in the U.S. continues to skyrocket. The average drug price increase from 2022 to 2023 was 15%, according to the United States Department of Health and Human Services. Some federal agencies say big pharma plays a role in keeping drug prices high for Americans. Lizzy McGrevy, Side Effects Public Media's community engagement specialist, spoke with Health Reporter Elizabeth Gabriel about why it's difficult to lower drug costs... Full

The New Old Age: When ‘Prior Authorization' Becomes a Medical Roadblock

(5/25, Paula Span, The New York Times) ...Medicare Advantage plans say it reduces waste and inappropriate care. Critics say it often restricts coverage unnecessarily...Responding to the inspector general reports, and to a rising tide of complaints, the federal Centers for Medicare and Medicaid Services has established two new rules to protect consumers and streamline prior authorization... Full

US FDA's Novel Approvals Peak Near Year-End, Analysis Of Last Decade Suggests

(5/27, Bridget Silverman, Pink Sheet) ...The Center for Drug Evaluation and Research's novel approvals concentrated in August, November, and December, while January and June were the slowest months, according to a Pink Sheet analysis of 2014-2023 data...The FDA's Center for Drug Evaluation and Research approved 456 new molecular entities and novel biologics during the 10 years from 2014-2023, the Pink Sheet's Novel CDER Approvals tracker and FDA databases show. That equates to an historically impressive average of 46 novel agents per year, or almost four (3.8) NMEs or novel biologics per month... Sub. Req'd

Colorado Drug Pricing Board Hits Back at Amgen Legal Challenge

(5/24, Celine Castronuovo, Bloomberg Law) ...A federal judge should decline to hear drugmaker Amgen Inc.‘s lawsuit against Colorado's prescription drug pricing review board over a vote to pursue a price cap for Enbrel, the state attorney general's office wrote Friday...In response to the filing, Amgen reiterated its criticisms of the board's actions, saying in an emailed statement that the board's review process was "flawed" and "haphazard." "Amgen believes the Board's actions are unconstitutional and we are confident the Court will give careful consideration to the issue," the company said... Sub. Req'd

Illinois Legislature Passes Bill to Limit Cost of Inhalers to $25 a Month

(5/23, Lisa Schencker, The Chicago Tribune) ...The Illinois legislature has passed a bill that would cap patient costs for prescription inhalers at $25 a month...The bill passed the House 87-21 on Wednesday, and now moves to the governor for his signature. When asked whether the governor plans to sign the bill, a spokesperson for Gov. J.B. Pritzer's office said in an email Thursday that he "will give it a careful review" once it reaches his desk... Full

Dutch Drugs Association Wants Clear, Predictable Reimbursement Procedures from Pharma Package

(5/27, Christoph Schwaiger, Euractiv) ..."We are still very much concerned, but less so than a year ago," VIG spokesperson Anton van Tuyl told Euractiv. While the VIG is happy to see the EP acknowledge the connection between protection periods and investments in R&D resulting in new medicines, it cannot understand why MEPs still want to reduce protection periods, even if only by six months. "The Commission proposal to reduce the protection period of eight years to six years would have been disastrous," van Tuyl told Euractiv... Full

France Remains the European "Leader" in General and Pharma Levies

(5/28, The Pharma Letter) ...French pharma trade group Leem (Les Entreprises du Medicament) has published its annual survey on the taxation of the pharmaceutical industry, compared to that of other European countries. This shows that France remains the European "leader" in general and sectoral levies, a context that threatens the sector's investment capacity in research and production of medicines... Sub. Req'd

Medicines for Ireland Calls for Urgent Action to Address the Escalating Issue of Medicine Shortages Impacting Irish Patients.

(5/24, Medicines for Ireland) ...Medicines for Ireland, the leading representative body for the generic, biosimilar, and value-added medicines industry, is highlighting the urgent need for action to address the increasing medicine shortages affecting the Irish population. A recent Red C survey reveals a concerning trend: 1 in 5 (20%) of individuals have been personally affected by medicine shortages in the past two years. Additionally, 22% report that family members or friends have been impacted totalling 38% of the population either directly or indirectly experiencing the consequences of these shortages... Full

Medicine Shortages Have Hit One-Third of Families Over Past Year

(5/27, Dominic Coyle, The Irish Times) ...More than one in three people say either they or their family have been impacted by ongoing shortages of certain medicines over the past year, with 60 per cent of a group surveyed saying the Government needs to improve its management of the crisis. And four in 10 say the problem is getting worse. More than 330 medicines are currently unavailable according to data from the medicines regulator – the Health Products Regulatory Authority and the Irish Pharmacy Union – according to a new study by generics specialist Azure Pharma... Full

Australia's Medicine Shortages Impacting More Than 400 Drugs

(5/26, Miriah Davis, 9 News) ...There are currently 424 medicines listed on the Therapeutic Goods Administration's (TGA) medicine shortage database, at least 20 of those are at critically low levels. Medicines in shortage include Ritalin to treat ADHD, and antibiotic Benzathine Penicillin for upper respiratory tract infections as well as antidepressant fluoxetine... Full

Panel Discussion On ‘From Fragile to Agile: Building Resilience in Pharma Supply Chain the Face of Disruptions'

(5/28, Express Pharma) ...Key Highlights: Building sound relationship with supplier partner is vital to attain agility in the pharma supply chain. Developing local resources and collaborating with them is crucial for the growth and balance in pharma supply chains. Self-sufficiency is very important for the growth of pharma supply chain... Full

Japan Reimburses Zolbetuximab, To Cut Price Of Imfinzi, Others

(5/24, Lisa Takagi, Pink Sheet) ...Japan's Ministry of Health, Labour and Welfare has announced its latest list of reimbursement prices for recently approved drugs, including for products which obtained their global-first approval in March. In this round, most of the new drugs were granted various forms of pricing premiums, while several including Nobelpharma Co., Ltd.'s Sargmalin (sargramostim) faced a net zero pricing gain despite being awarded several premiums, due to methodology which takes into account a rule around costs.... Sub. Req'd

International Health Regulation Changes Focus On Equitable Access And Production Capacity

(5/27, Ian Schofield, Pink Sheet) ...The final version of amendments to the IHR is due to be discussed at this week's World Health Assembly, alongside the text of the proposed global pandemic treaty. Much of the talk ahead of the World Health Assembly this week has been around the World Health Organization's draft pandemic treaty, discussions on which came to an end on Friday... Sub. Req'd

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