Monday, November 18, 2024

Amneal Dreams Of Building On Biosimilars To Compete With Other Players

(11/15, Urte Fultinaviciute, Generics Bulletin) ..."We would love to integrate completely and head-on compete with Sandoz, Celltrion, Amgen," said co-founder and co-CEO Chirag Patel during the FY2024 Q3 earnings call...Last quarter, Amneal commented that "inhalation is a new vector of growth for our business" and announced that its generic version of Teva's ProAir HFA (albuterol sulfate) inhaler will be the first launch, despite the two companies being in a legal battle over patent infringement for quite some time now. During the Q3 earnings call, the management did not mention the albuterol inhaler even once, but Chintu Patel said that they were "excited about our inhalation pipeline with our first inhalation product pending approval soon and many more to come in the years ahead."... Global Sub. Full

ANI Outperforms With Generics Amid Diversification Push

(11/15, Adam Zamecnik, Generics Bulletin) ...ANI reported a net revenue of $148.3m for the third quarter of the 2024 financial year, which marks a 12.5% year-over-year growth compared to a net revenue of $131.8m in the same time period in the previous fiscal year. A large bulk of the net revenue was earned through the firm's generics, established brands, and other products segment. Overall, ANI earned $91.9m in the segment, down by a tenth, with $78.2 (+10.8%) made through the sale of generics and $13.7m (-56.6%) in the other categories... Global Sub. Full

Formycon Receives Positive CHMP Opinion for FYB203 (Aflibercept), A Biosimilar Candidate to Eylea® Under the Tradenames AHZANTIVE® and Baiama®

(11/18, Formycon AG) ...Committee for Medicinal Products for Human Use of the European Medicines Agency recommends approval of FYB203 for the treatment of Neovascular Age-Related Macular Degeneration (nAMD), along with several other serious retinal diseases. Approval decision by the European Commission expected in the second half of January 2025... Full

Samsung Bioepis Gets Positive EMA Opinion for Biosimilars Targeting Amgen's Prolia, Xgeva

(11/18, Lee Han-soo, Korea Biomedical Review) ...Samsung Bioepis said it has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for marketing authorization of Obodence and Xbryk, biosimilars of Amgen's Prolia and Xgeva...The company expects final approval from the European Commission within two to three months, a step that will officially allow the products to enter the European market... Full

FDA Nod for Azurity's Danziten Will Allow Patients to Take Leukemia Med Without Fasting

(11/15, Kevin Dunleavy, Fierce Pharma) ...Azurity Pharmaceuticals has earned FDA approval for Danziten (nilotinib), a new formulation of Novartis' chronic myeloid leukemia (CML) blockbuster Tasigna that doesn't require patients to take their medication on an empty stomach... Full

Eli Lilly and Novo Want to Shake Off Ozempic Copycats. Are They Ready to Meet Demand?

(11/17, David Wainer, The Wall Street Journal) ...Pharmaceutical companies are typically rewarded for their innovation with years of market exclusivity before cheaper generics enter the scene. But for diabetes and obesity drugs like Ozempic and Zepbound, known as GLP-1s, cheaper copycats emerged almost immediately. This is due to a provision that permits drug compounders to produce copies during periods of shortage... Sub. Req’d

Dr Reddy's, FDC Recall Generic Medications in US Over Manufacturing Issues

(11/17, Press Trust Of India) ...Dr Reddy's Laboratories and FDC Ltd are recalling generic medications in the US market due to manufacturing issues, according to the US health regulator. As per the latest Enforcement Report by Food and Drug Administration, the US-based subsidiary of Dr Reddy's Laboratories is recalling multiple strengths of Morphine Sulfate extended-release tablets in the US... Full

Pharmaceutical Giants to Pay Baltimore $266M in Opioid Epidemic Lawsuit

(11/15, Minnah Arshad, USA Today) ...A jury found Texas-based healthcare products company McKesson liable for $192 million in damages and Pennsylvania-based drug wholesaler Cencora for $74 million. Baltimore accused the companies of failing to report "suspicious orders" of prescription drugs such as oxycodone and hydrocodone to federal authorities, subsequently contributing to the city's opioid epidemic... Full

Can Global Policies to Boost Biosimilar Adoption Work in the US?

(11/17, The Center For Biosimilars) ...Joining us for this special episode is Craig Burton, executive director of the Biosimilars Council and senior vice president of policy and strategic alliances at the Association for Accessible Medicines. Craig is a leading voice in the biosimilar space, and together, we'll explore a fascinating and timely question: Can global policies to boost biosimilar adoption work in the US?... Full

Video: Amazon's Move into the Generic Drug Market: Panel Discussion

(11/16, FOX Business) ...Jack Otter and the ‘Barron's Roundtable' panelists discuss Amazon's expansion into the generic drug market... Full

Drug Patent Reform Plans in a Holding Pattern

(11/16, Peter Sullivan, Victoria Knight, Adriel Bettelheim, Axios) ...Efforts in Congress to address drug prices now mostly focus on proposals to revise patent laws that pharmaceutical companies use to protect their innovations...It would crack down on "patent thickets," the practice of taking out overlapping patents around one drug...Pharmaceutical interests argue manufacturers need to be able to use the intellectual property system to innovate after a drug is rolled out... Full

1 Big Thing: Republicans' Drug Pricing Puzzle

(11/16, Peter Sullivan, Victoria Knight, Adriel Bettelheim, Axios) ...The reality is the ongoing Medicare drug pricing negotiations created by the Democrats' Inflation Reduction Act may be the best bet, at least in the near term, to bring down some pharmaceutical prices. The big picture: Growth in U.S. brand-name drug prices has outpaced inflation in recent years, and federal projections show the retail prescription drug market will total $690 billion by 2031... Full

McClellan: Trump Could Use Trade Rep To Press For Lower Drug Prices

(11/15, Jessica Karins, Amy Lotven, InsideHealthPolicy) ...Mark McClellan, who served as head of both FDA and CMS during the George W. Bush administration and who is currently director of the Robert J. Margolis Center for Health Policy, said he expects to see Trump approach drug pricing somewhat differently than he did during his first administration, thanks to changes like the implementation of the Inflation Reduction Act (IRA) and changes to Medicare Part D... Sub. Req’d

Draft Part D Rule Could Hand Trump Quick Way To Reshape IRA Drug Negotiation Policies

(11/15, Maaisha Osman, InsideHealthPolicy) ...Biden's CMS is trying to use a draft prescription drug benefit rule pending at the White House to clarify and codify how it implements the Inflation Reduction Act drug-price controls, but the rule could end up giving the incoming Trump administration a way to quickly shape its own Medicare drug price negotiation policies. The proposed contract year 2026 policy and technical changes rule hit the Office of Management and Budget on Sept. 20, before Donald Trump won the November presidential elections... Sub. Req’d

Biotech Lobby Calls On CMS To Prevent Abuse Of Part D Redesign

(11/15, Gabrielle Wanneh, InsideHealthPolicy) ...Medicare Part D plan sponsors are asking for higher rebates from drug makers in response to the increased "phase-in costs" plans will need to cover when the benefit redesign kicks in at the start of 2025, according to a biotechnology lobbying group that is asking CMS to step in. The Biotechnology Innovation Organization (BIO) is pressing the agency to increase its oversight of Part D formulary policies, including what it says are threats from plans to impose prior authorization or step therapy if they don't get higher rebates, during the benefit redesign called for by the Inflation Reduction Act... Sub. Req’d

Trump's US FDA User Fee Cycle: ‘An Underappreciated Threat'

(11/16, Sarah Karlin-Smith, Pink Sheet) ...Trump's expected HHS Secretary nominee, Robert F. Kennedy Jr., has shown an interest in eliminating user fees, presenting a key challenge for industry as the 2027 reauthorization process nears. If the administration is intent on lessening the influence of user fees, few believe congressional appropriators would fill the gap with taxpayer dollars. Trump officials also could use the reauthorization agreement and subsequent "must-pass" legislation to enact their agenda for the agency... Global Sub. Full

Drug Markets Uneasy About RFK Jr.

(11/15, Nathaniel Weixel, Joseph Choi and Alejandra O'Connell-Domenech, The Hill) ...PhRMA president and CEO Stephen Ubl said in a statement Thursday said the group wants to "work with the Trump administration to further strengthen our innovation ecosystem and improve health care for patients." It did not mention Kennedy. In a note to clients, Raymond James analyst Chris Meekins said Kennedy "likely will lead to significantly more volatility in health markets, making navigating policy risks far more challenging."... Full

Pharma, Long Criticized by RFK Jr., Looks for Ways to Work With Him

(11/15, Jonathan D. Rockoff and Jared S. Hopkins, The Wall Street Journal) ...The Pharmaceutical Research and Manufacturers of America, a trade group, sought to strike a constructive tone, saying it wanted to "work with the Trump administration to further strengthen our innovation ecosystem and improve healthcare for patients." The Biotechnology Innovation Organization said it looked "forward to working closely" with Trump and his administration. "The public health, economic security and our national security are best served by strong leadership that respects and advances science, nutrition and medicine and ensures that the United States and our allies continue to lead the world in biotechnology," it added... Sub. Req’d

Stalemate Breaks On Telehealth Prescriptions of Stimulants and Addiction Treatment

(11/15, Mario Aguilar and Katie Palmer, STAT) ...Federal officials on Friday said health providers could prescribe drugs for opioid addiction and ADHD over telehealth for one more year, ending a months-long stalemate among policymakers. During the pandemic, the Drug Enforcement Agency issued temporary rules that allowed providers to prescribe controlled substances like buprenorphine and Adderall without first meeting a patient in person. Those rules were set to expire on Jan. 1, and have now been extended until the end of 2025. The extension kicks the resolution of a years-long debate — one that has already elicited nearly 40,000 comments on earlier proposed rules — to the second Trump administration, and agency leadership that is yet to be determined... Full

Doctors Say RFK Jr.'s Anti-Ozempic Stance Perpetuates Stigma and Misrepresents Evidence

(11/17, Meg Tirrell, CNN) ...Robert F. Kennedy Jr. has pledged to tackle high rates of chronic diseases such as diabetes and obesity as President-elect Donald Trump's pick to lead the US Department of Health and Human Services. They're goals that many in the public health world find themselves agreeing with — despite fearing what else the infamous anti-vaccine activist may do in the post... Full

Medicaid Fuels US Coverage of Novo, Lilly Weight-Loss Drugs

(11/18, Chad Terhune, Reuters) ...U.S. government health plans account for the lion's share of coverage for popular new weight-loss drugs, far beyond the reimbursement available from private employers and insurers, according to an analysis shared with Reuters. State Medicaid programs for low-income families are the single biggest source of coverage, giving 31.6 million people access to Novo Nordisk's Wegovy or Eli Lilly's Zepbound, according to the AXIACI Obesity Coverage Nexus, a database produced by the Leverage consulting firm... Full

Lilly Sues HHS for Ending Planned 340B Drug Program Cash Rebates

(11/15, Mary Anne Pazanowski, Bloomberg Law) ...Lilly's most recent attempt at curing the program involves implementing a cash replenishment model in place of a product replenishment model. Under this new system, Lilly would sell its drugs to 340B-covered entities at market prices, then the entity would submit a claim to Lilly for a cash rebate to ensure it paid no more than the 340B discounted price. This would speed up and streamline program, it said... Sub. Req’d

CVS Loses First Round in Bid to Avoid Court in Antitrust Case

(11/15, Mary Anne Pazanowski, Bloomberg Law) ...Four independent pharmacies won the first round in their antitrust case against CVS Health Corp. when a federal judge in Arizona refused to enforce a contract provision requiring an arbitrator to decide if the claims should be resolved out of court. Provisions in the parties' network provider agreements delegating the arbitrability question were so one-sided and unfair as to shock the conscience and therefore were unenforceable under Arizona law, the US District Court for the District of Arizona said in an opinion posted Thursday... Sub. Req’d

MedPAC Explores Drug Coverage Plan Problems As Part D Stand-Alone Plan Access Declines

(11/15, Cathy Kelly, Pink Sheet) ...MedPAC is exploring the stability of the Medicare Part D standalone drug plan market given a notable decline in the number and attractiveness of plans available in 2025. The group is analyzing several actuarial disadvantages associated with standalone drug plans versus Medicare Advantage plans with a drug benefit and considering the impact of the Inflation Reduction Act's Part D redesign. MedPAC staff will present more market analyses to commissioners at a spring meeting, which could lead to policy recommendations... Global Sub. Full

GAO Finds Persistent Challenges in FDA's Ability to Hire and Retain Inspectors

(11/15, Joanne S. Eglovitch, Regulatory Focus) ...For the report, GAO interviewed FDA officials about their efforts to maintain a staffing sufficient pool as well as their experiences conducting in-person inspections. The audit was conducted from April 2023 to November 2024. FDA conducted 621 foreign and 444 domestic inspections in fiscal year (FY) 2023, which was 36% lower than in FY 2019, according to the report FDA attributed the decrease to "reduced investigator capacity."... Full

Pipes: Drug ‘Affordability' Boards Won't Really Help Patients

(11/18, Sally C. Pipes, Boston Herald) ...The decision could have significant consequences not just in Colorado but across the country. Ten other states have recently established prescription drug affordability boards (including Massachusetts). They're closely watching Colorado's decision — and may copy it in the months and years to come. The forthcoming price controls will inevitably restrict patients' access to Stelara and other drugs. In the process, they'll stifle research into future treatments and cures that could save lives. State-imposed price controls won't actually limit what most patients pay... Full

European R&D Spend Outpaced by USA – With Increasing China Competition

(11/18, The Pharma Letter) ...New research published by the European Federation of Pharmaceutical Industries and Associations (EFPIA) provides in-depth analysis of the economic footprint of the pharmaceutical industry in Europe, across member states and compares Europe to other regions of the world. It shows a ‘strong and growing' industry which contributed a total of 311 billion euros ($328 billion) to the European Union-27 economy in 2022... Sub. Req’d

Maintain Current Patent Protection Baseline, Says Czech Innovative Pharma Head

(11/17, Aneta Zachová, Euractiv) ...The European Union's pharmaceutical reforms must maintain the current patent protection baseline, says David Kolár, executive director of the Czech Association of Innovative Pharmaceutical Industry. Kolár spoke in-depth with Euractiv's Aneta Zachová. He told Euractiv that the current proposals risk undermining innovation and driving investment away from Europe... Full

BGMA Names Accord's Carter To Lead Women's Networking Group

(11/15, Dave Wallace, Generics Bulletin) ...Clara Carter, UK country manager for generics at Accord Healthcare, has been named by the British Generic Manufacturers Association as the first chair of the organization's new Women's Networking Group. The aim of the new group is to create learning and networking opportunities for women in the generic and biosimilar industry and support them in their career development... Global Sub. Full

AstraZeneca: AI Regulations ‘Tricky' To Interpret & Navigate

(11/15, Eliza Slawther, Pink Sheet) ...Pharmaceutical companies are trying to navigate emerging global guidance and regulation of AI and data, something that can be difficult given the different approaches taken in different jurisdictions, according to AstraZeneca's director of data and AI policy, Margi Sheth... Global Sub. Full

Pharma Sector Must Grow Beyond Making Generic Drugs, Says Rajeev Singh

(11/16, Times Of India) ...Business in the pharmaceutical sector in India can reach the projected value of US$130 billion – a two and a half times growth – in six years only if it expands beyond manufacturing generic drugs, according to drugs controller general Rajeev Singh Raghuvanshi. He said India needs to replicate its success in generic medicine manufacturing across biological drugs, research and manufacturing, medical devices, digital health and drug discovery research... Full

Local to Global: 14 Nations Keen to Adopt India's Generic Pharmacy Model

(11/15, Priyanka Sharma, Mint) ...Inspired by India's efforts to make affordable medicines accessible to the public, 14 countries from the Global South, including Taliban-ruled Afghanistan, are considering adopting India's generic pharmacy model, according to two people familiar with the development... Full

The Rise Of India's Pharmaceutical Industry To A Forecasted $450 Billion

(11/16, Karen Kashyap, Forbes) ..."Despite the challenges, India aims to become the world's largest pharmaceutical market by volume, and rank amongst the top five pharma sectors by value," according to Dr. Kanica Rakhra, Asia Global Fellow at the University of Hong Kong. "These ambitious goals, if realized, will not only boost India's economy but also contribute significantly to global health security, by providing affordable medicines and medical devices to both developing and developed nations."... Full

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