Thursday, June 4, 2026

 

 

Alvotech Resubmits BLAs For Simponi, Eylea Biosimilars

(6/4, RTT News) ...Alvotech (ALVO), a biotechnology company, on Thursday said it has resubmitted Biologics License Applications (BLAs) to the U.S. Food and Drug Administration (FDA) for AVT05, a proposed biosimilar to Simponi and Simponi Aria, and AVT06, a proposed biosimilar to Eylea...Under a partnership with Teva Pharmaceutical Industries Ltd. (TEVA), Alvotech is responsible for the development and manufacturing of AVT05 and AVT06, while Teva handles commercialization... Full

 

Alvotech, Teva Resubmit 2 Proposed Biosimilar Applications to the FDA for Retinal Treatment

(6/4, MT Newswires) ...The regulatory fillings follow responses to a Post-Application Action letter and a recent manufacturing facility inspection in Reykjavik, Iceland, with the proposed drugs targeting chronic inflammatory issues and retinal disorders, the company said. Teva will manage the commercial rollout for both medications, which are anticipated to undergo a six-month regulatory evaluation, it said... Full

 

Alvotech Announces Resubmission of U.S. Biologics License Applications for AVT05, a Proposed Biosimilar to Simponi® and Simponi Aria®, and AVT06, a Proposed Biosimilar to Eylea®

(6/4, Alvotech) ..."These resubmissions represent an important milestone following extensive work across our manufacturing and quality organization," said Lisa Graver, Chief Executive Officer of Alvotech. "We have worked closely with the FDA throughout this process, including responding to the agency's Post-Application Action Letter and supporting a routine inspection of our Reykjavik facility in May. As previously disclosed, we believe the outcome of the recent inspection demonstrated the strong cGMP fundamentals of the site and the robustness of the improvements implemented since last year. We remain focused on execution, operational discipline and bringing high-quality biosimilars to patients worldwide."... Full

 

 

US Legislation Targets US-China Dealmaking Amid Fears Of Ceding Biotech Leadership

(6/3, Jessica Merrill, Pink Sheet) ...The legislation would make US pharmaceutical licensing deals, joint ventures and equity investments with Chinese companies subject to Treasury Department review. Regulations would have to be implemented within a year and require consultation with the Health and Human Services and Defense departments, as well as the Director of National Intelligence... Global Sub. Full

 

Stakeholders Urge Senators To Crack Down On Patent Thickets With ETHIC Act

(6/3, Gabrielle Wanneh, Inside Health Policy) ...The Eliminating Thickets to Increase Competition Act (ETHIC) Act is key legislation set to be discussed by the Senate Judiciary intellectual property subcommittee Thursday (June 4)...John Murphy, CEO of the Association for Accessible Medicines (AAM), tells Inside Health Policy the ETHIC Act is crucial for combating brand drug companies' use of terminal disclaimers that create the conditions for patent thickets to be established over time. A terminal disclaimer is a legal filing in which brand companies state that a newer patent they want to file on a particular drug will expire at the same time as the patent or patents already filed for the drug at an earlier time... Sub. Req'd

 

CSRxP Encourages House Judiciary IP Subcommittee to Advance Bipartisan, Market-Based Solutions to Lower Drug Prices by Fostering Competition

(6/3, CSRxP) ..."CSRxP encourages members of the Committee to reject Big Pharma's debunked rhetoric claiming high prices and extended periods of exclusivity are necessary for innovation, and instead advance bipartisan, market-based solutions to lower drug prices by fostering greater competition, including the ETHIC Act that addresses Big Pharma's patent thickets, and the Skinny Labels, Big Savings Act, that would restore certainty to the skinny-label pathway and bring lower-cost generics and biosimilars to market more quickly."... Full

 

House Rules Advances FDA Spending Bill, Rules Out Tariff Amendment

(6/3, Jessica Karins, Inside Health Policy) ...The amendment, which comes after years of concern about shortages of sterile injectable drugs, particularly cancer treatments, would ensure the agency does not deprioritize review, inspection, import screening or shortage-mitigation activities for those drugs, while maintaining FDA safety standards... Sub. Req'd

 

Editorial: Tariffs Pressure Pharmaceutical Intellectual Property

(6/3, Legis1) ...The medicine patent balance question is genuinely hard, and it is made harder by an administration that has simultaneously tried to lower drug prices through executive fiat and raise costs on imported patented medicines through tariffs. Congress has been largely reactive. Thursday's hearing is an opportunity to get ahead of the curve, or, at a minimum, to put the competing interests on the record before the next executive action reshapes the landscape again... Full

 

Chairman Rick Scott Exposes How Overseas Drugs Harm Americans During Aging Committee Hearing

(6/3, The Special Committee on Aging) ...Today, Special Committee on Aging Chairman Rick Scott led a hearing titled "Poisoned Pills: The Human Cost of Dangerous Foreign Drugs" to highlight how substandard and contaminated drugs manufactured overseas, particularly in India and China, harm American patients, undermine trust in generics, and expose weaknesses in FDA's foreign inspection and oversight system... Full

 

'There's Going To Be A Learning Curve For Everyone' - Mintz's Gutman On Biosimilar Streamlining

(6/3, Dave Wallace, Generics Bulletin) ...Sige Gutman, chair of the life sciences litigation practice and co-chair of the patent litigation practice at US law firm Mintz, speaks to Generics Bulletin about the impact of biosimilar streamlining...Gutman highlights the reduced timelines and increased opportunity for rival biosimilar sponsors to "leapfrog" one another in the development process, as well as the more complex environment that streamlining will create for originators seeking to defend their brands... Global Sub. Full

 

FDA Updates Manufacturer Communications Guidance to Emphasize Application to Devices

(6/3, Ferdous Al-Faruque, Regulatory Focus) ...As with the previous guidance, FDA noted that payors have stated that, in certain situations, they need information on medical products that have not yet received marketing authorization to plan for coverage and reimbursement decisions, including unapproved uses of the products, which may raise public health concerns. The agency said the guidance attempts to balance the needs of industry, payors, and other stakeholders, with its responsibility to protect public health... Full

 

Law Firm Asks US to Investigate Eli Lilly's Drug Discount Policy

(6/3, Nyah Phengsitthy, Bloomberg) ...A letter sent Wednesday from Hall, Render, Killian, Heath & Lyman, P.C. is asking the US Health Resources and Services Administration and the HHS Office of Inspector General to open an investigation into a new policy from Lilly that requires all healthcare providers under the federal 340B Drug Pricing Program to submit claims-level data for dispensing of the company's drugs... Full

 

Lilly Says Hospital 'Boycott' Over Claims Data Demands Has Forced its Hand

(6/4, Elizabeth S. Eaton, FirstWord PHARMA) ...Under the 340B programme, eligible hospitals that serve uninsured and low-income patients receive significant discounts on drugs. However, pharmaceutical companies have long claimed that the programme is rife with abuse, and that large hospital systems exploit the discounts by inflating prices for both uninsured patients and insurers... Full

 

 

Zynlonta's Confirmatory Lymphoma Study Gets Investor Cold Shoulder

(6/3, Anna Bratulic, FirstWord PHARMA) ...Investors appeared to focus on the LOTIS-5 study's safety findings and lack of a clear overall survival (OS) advantage, sending shares down nearly 46% in after-hours trading Wednesday... Full

 

 

Q&A: Dr. Reddy's CEO on Generic Semaglutide and the GLP-1 Market Ahead

(6/3, Stephen Appezzato, Pharmaceutical Commerce) ...Erez Israeli explains how Dr. Reddy's approached commercial readiness for its generic semaglutide launch in Canada and what vertical integration in peptide manufacturing means for the GLP-1 market... Full

 

Daewoong's Dupixent Deal Is 'Important Turning Point'

(6/3, Dean Rudge, Generics Bulletin) ...Daewoong has signed twin agreements with Chime Biologics covering development, manufacturing and eventual commercialization of a proposed Dupixent biosimilar, giving the Korean firm an end-to-end platform... Global Sub. Full

 

How Comfortable Are Neurologists With Biosimilar Prescribing?

(6/3, Stanton Mehr, Biosimilars Review & Report) ...Another factor impacting neurologists' biosimilar prescribing is not so obvious: A significant portion have been prescribing rituximab and its biosimilars off label to treat some neurologic disorders, including myasthenia gravis, multiple sclerosis, and neuromyelitis optica spectrum disorder. And rituximab biosimilars were approved since 2018... Full

 

Faster Doesn't Mean Easier: Development Impacts of a New Biosimilar Regulatory Landscape

(6/3, Kimberly Salgado, PharmTech) ...While these changes to regulatory approaches will ultimately reduce the time and resources required to develop biosimilars, they also represent a fundamental shift in strategies for biosimilar submissions. Understanding the implications of the new regulatory guidance and publications, including their impact on data generation and the competitive landscape, will be crucial to future success in the biosimilar field... Full

 

The 2026 Patent Cliff Is Not the Real Risk. Execution Is.

(6/3, Rahul Mittal, Dr. Reddy's Laboratories, PharmaLive) ...The 2026 patent cliff should be viewed not only as a market event, but as an execution discipline test...The first leak is sequencing...The second leak is contract activation...The third leak is allocation...The fourth leak is field focus... Full

 

 

Lilly, Boehringer to Slash at Least $1B Each from Planned Investments in Germany

(6/3, Kevin Dunleavy, Fierce Pharma) ...The cutbacks are significant. Lilly will slice its planned investment of 2.3 billion euros ($2.7 billion) in half, while Boehringer is cutting its domestic spending by 900 million euros ($1 billion). The German business newspaper Handelsblatt first reported the companies' decisions Wednesday... Full

 

Strengthening U.S. Pharmaceutical Supply: SCHOTT Pharma Inaugurates Expanded Vial Production in Lebanon, PA

(6/4, SCHOTT Pharma) ..."The expansion contributes to SCHOTT Pharma's long-term global growth strategy, with a strong local-for-local presence in the U.S. and scaled manufacturing capacity for high-value solutions that address key trends in the pharmaceutical industry, such as biologic medications and novel drug formulations," says Christian Mias, CEO of SCHOTT Pharma... Full

 

As Akeso Takes Center Stage at ASCO, China Biotech Industry Cements its Coming of Age

(6/3, Angus Liu, Fierce Pharma) ..."Over the last three years, especially in emerging fields like bispecifics and ADCs, China has become so essential, some are even saying that if a session doesn't include presentations or data from China, it's simply not worth attending," Dajun Yang, M.D., Ph.D., CEO of Ascentage Pharma, said in an interview with Fierce. "In sectors like bispecifics, bispecific ADCs or protein degraders, up to a third of the studies presented are coming out of China."... Full

 

AstraZeneca CEO: AI is Affecting Every Part of Our Company

(6/4, CNBC) ...AstraZeneca CEO Pascal Soriot joins CNBC's Angelica Peebles to discuss the most promising drugs in AstraZeneca's pipeline. He says the future is about innovating into new indications with the drugs and technologies they already have in house. He says in the last 3 years the company has averaged one positive trial result readout every month. As far as dabbling in AI, the company created a specialized AI unit to help accelerate research and discovery... Full

 

Bristol Myers Turns Focus to AI Costs after Broad Rollout to Workers

(6/4, Drew Armstrong, Endpoints News) ...CEO Chris Boerner said he's deployed a finance team to assess the company's spending, following a period in which the goal was to get AI tools in the hands of as many people as possible to encourage its use...He declined to share any numbers on Bristol Myers' returns from AI or how much it's spending. AI providers have reported explosive growth in revenue. Anthropic, for example, has reportedly said it expects about $10.9 billion in sales in the second quarter, double the previous quarter. Much of that revenue comes from corporate clients who use its chat, productivity and coding services... Sub. Req'd

 

Alnylam Strikes $2B AI Deal with Inceptive to Speed Up RNAi R&D

(6/3, Elizabeth S. Eaton, FirstWord PHARMA) ...Alnylam Pharmaceuticals is hoping Inceptive Nucleics' AI technology can add some fuel to its RNAi drug development engine. The biopharma is targeting an "ambitious" pipeline expansion to meet its five-year strategy goals, and it thinks Inceptive's generative AI models will be able to boost its innovation speed... Full

 

Exclusive: Lundbeck Taps Cradle for Antibody Design

(6/3, Rowan Walrath, Chemical & Engineering News) ...Cradle's platform is trained on protein sequences and assay data, including information about binding, thermostability, and expression-"things that people typically want when they're trying to engineer a molecule for different types of modalities that are therapeutically relevant," Cradle cofounder and CEO Stef van Grieken tells C&EN. Those data inform which tweaks Cradle might suggest to improve antibodies... Full

 

 

Merck Launches Innovation Center in Shenzhen

(6/4, China Daily) ...Merck, a major science and technology company, started operations of a new innovation and collaboration center in Shenzhen, Guangdong province, on Monday. This center is dedicated to serving the Guangdong-Hong Kong-Macao Greater Bay Area by uniting efforts from government, industry and academia to foster technological breakthroughs on a global scale... Sub. Req'd

 

Pharma Exports to US Seen Muted This Year

(6/3, Teena Thacker, The Economic Times) ...Experts said inventory correction, product cycle timing, and above-normal buying in March 2025 ahead of tariffs have also created a high base that current shipments struggle to match... Full

 

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