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The European Medicines Agency (EMA) has published a draft reflection paper that signals a potential evolution in the regulatory landscape for biosimilar development within the EU. 1,2 The reflection paper also highlights the limitations and diminishing value of CES in many biosimilar development programmes.
Voices Q&A Profiles Biotech Spotlight First 90 Days Opinions Topics Biotech Commercialization Leadership Manufacturing Patient Pharma Policy & Regulation Research & Development Library Events Press Releases PharmaVoice 100 Nominate 2024 PV100 2023 PV100 Sign up Search Sign up Search An article from Megablockbusters are the holy grail.
Alvotech has moved one step closer to entering the Eylea (aflibercept 2 mg) biosimilar market, after a European Medicines Agency (EMA) panel recommended approval of its copycat biologic. Go deeper with GlobalData Reports LOA and PTSR Model - Aflibercept Biosimilar in Age Related Macular. CucuMberStudio via Shutterstock.
In 2024, Pharmapack Europe, the two-day exhibition and conference for pharma’s drug delivery and packaging industry will introduce two brand new zones to the flagship event. Bio packaging zone . Pharmapack’s bio packaging zone builds on its long history of being at the forefront of innovations in biological drug delivery.
“approval [of Pyzchiva ® (biosimilar ustekinumab)] of is a crucial step towards offering European patients an additional safe and effective treatment option” Pharmaceutical company Sandoz has announced that the European Commission (EC) has granted marketing authorisation for Pyzchiva ® (biosimilar ustekinumab ).
What are the top 3 trends that defined pharma manufacturing in India and globally in 2024? In 2024, the pharmaceutical manufacturing landscape underwent transformative changes, driven by technological innovations, regulatory adaptations, and evolving global demands. Regulatory bodies in the U.S. and Europe. and Europe.
ASBM and GaBI Webinar Examines Policy Challenges to Interchangeable Biosimilars On November 30, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted I nterchangeable Designation for Biosimilars- Ensuring Continuity of Patient Care: Upholding Interchangeability Status for Biosimilars.
prescribers have high confidence in the safety and efficacy of biosimilars, a majority (58%) oppose third-party switching of a patient’s biologic medicine for non-medical (e.g. state law, only biosimilars which are interchangeable may be substituted by a pharmacist without contacting the prescriber. and worldwide.”
By Sara M Keup In reviewing some new 2025 pharmacy rules/laws a couple interesting changes caught this bloggers attention: As of December 30, 2024, Missouri has rolled out new rules related to prescription drug delivery requirements. The California Board of Pharmacy updated many of the application forms and guidelines in late 2024.
Among the authorized medicines are six biosimilars and two generic drugs. Drug Solutions Podcast: Growth and Advancements in Fill/Finish Felicity Thomas June 25th 2024 Podcast In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.
Biopharmaceutical companies developing Alzheimer’s disease innovator drugs have witnessed a flurry of acquisitions over the past few years, surging in total deal value by more than 780% from $2 billion in 2022 to almost $18 billion in 2024. Go deeper with GlobalData Reports Biosimilars in Pharmaceuticals: Peptide-based compositions for Alzh.
Celltrion USA has received approval from the US Food and Drug Administration (FDA) for Humira (adalimumab) biosimilar, Yuflyma (adalimumab-aaty) , for multiple indications. Yuflyma represents the company’s fifth biosimilar and second anti-TNF biosimilar to receive US FDA approval.
By GlobalData Learn more about Strategic Intelligence In 2024, the business being acquired reported net sales of Nkr62m and is poised to play a significant role in helping Navamedic achieve its revenue target of Nkr1bn. Can pharma tariffs “Make America Manufacture Again”? Don’t let policy changes catch you off guard.
In preclinical studies, HLX15 is highly similar to daratumumab Amgen Launches First Humira (adalimumab) Biosimilar Amjevita in the US Date- February 01, 2023 Product: Amjevita The company has launched Amjevita (adalimumab), the first biosimilar referencing blockbuster drug Humira on the US market for certain serious inflammatory diseases.
The FIE determination released in fall 2023 involves the Reference Product AbbVie’s Humira (adalimumab) and two interchangeable biosimilars—first approved is Cyltezo (adalimumab-adbm), filed by Boehringer Ingelheim Pharmaceuticals, Inc, which was followed by Abrilada (adalimumab-afzb), filed by Pfizer.
Over ABP 938 Biosimilar to EYLEA On January 10, 2024, Regeneron Pharmaceuticals, Inc. Amgen”) alleging infringement of 32 patents under the BPCIA based on Amgen’s submission of an aBLA for ABP 938, a proposed biosimilar of EYLEA (aflibercept). One patent related to packaging: S. Regeneron”) filed a Complaint in the U.S.
Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. The draft guidance recommends that no more than 15 questions are included in the briefing package. CBER will not commit to reviewing packages greater than 250 pages.
Regeneron seeks a PI schedule to “ensure an orderly process that will result in resolution of its forthcoming motion for PI before May 17, 2024,” when its regulatory exclusivity period ends. A status conference took place today January 5, 2024 in relation to Regeneron’s emergency motion. Patent Nos. Patent Nos. Design Patent Nos.
FDA intends the Guidance to provide “clarity and flexibility” to trading partners to “help ensure continued patient access to prescription drugs as the supply chain transitions to the interoperable, electronic product tracing at the package level under the DSCSA” while supporting “continued availability of products to patients.”
Livornese — FDA issued a Federal Register notice on September 13, 2024, seeking feedback on the Integrated Review format that the Center for Drug Evaluation and Research (CDER) began using as part of its New Drugs Regulatory Program (NDRP) modernization effort several years ago. Comments are due by December 12, 2024. By Deborah L.
While a handful of incentives are offered by the reform package, they are overshadowed by the potential drawbacks for the innovative sector. Generic and biosimilar firms are likely to heavily utilise this provision, and earlier market entry may lead to faster price drops for branded drugs.
I joined as the CEO of this company around midJune 2024. And, since most of the future growth will come from biologics and biosimilars, how will India make its mark as a global biosimilar CDMO market? Over the past nine months, our primary focus has been on building a world-class team and operational structure.
3558 ) on January 25, 2024. Conclusion Although the BIOSECURE Act has not been passed by Congress (or signed by the President), its sponsors are expected to push for its inclusion in the FY25 NDAA or as part of other omnibus legislative packages that arise this year. House of Representatives ( H.B. 7085 ) and Senate ( S.B.
Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. Under § 820.45, FDA also requires manufacturers to inspect labeling and packaging for accuracy.
Head to our online registration page to take advantage of our most competitive rates and group packages: [link] Image 27 June, 2025 Bookmark this Oncology Merck at ASCO 2025: Cancer is a constellation of many rare d. Market Access Sponsored Bridging research and clinical guidelines – interactive stra.
Experts praise the reforms to rare disease and antimicrobial research, but they worry that some provisions in the EU Pharma Package may harm innovation on the continent, contrary to its stated objectives. Reports Biosimilars in Immunology Data Insights The gold standard of business intelligence.
Spanning pharma machinery, packaging, analytical instruments, laboratory technologies, ingredients, and beyond, it offers a comprehensive platform for stakeholders to engage in transformative dialogues and foster strategic partnerships. With exports nearing $27.84 VP- Advanced Biotech Lab, IPCA Labs; among other relevant topics.
as in most advanced nations, a prescribing physician may substitute any biosimilar for its reference product. However, substitution of biosimilars at the pharmacy level is controversial, opposed by majorities of physicians worldwide, and banned in many countries including most of Western Europe. In the U.S. In the U.S., In the U.S.,
Trikafta, known under the brand name Kaftrio in Europe, is the best-selling cystic fibrosis drug in the world, generating revenue of $11.02bn in 2024. Kaftrio loses patient protection in 2037, at which point biosimilars are set to enter the market. How will RFK Jr’s American dream for vaccines play out?
With a focus on redefining the pharmaceutical industry in the post-COVID era, PharmaLytica 2024 offered a platform for stakeholders to engage in discussions covering the full spectrum of pharma machinery and packaging, lab analytical and cleanroom solutions, and pharmaceutical ingredients. We exported $ 27.8
In 2024 alone, an estimated 30,113 preventable deaths oc- curred in people under 19 years of age due to T1D, with nearly 40 per cent (11,352) in sub-Saharan Africa – the high- est burden of any region. In response to this pressing issue, dedicated initiatives have been established to provide diabetes care specifically for CYP.
billion in 2024 to $10.3 While the overall MG market is expected to experience growth until 2034, continued generic erosion and the entry of biosimilars will be important barriers to growth. Generic erosion and the entry of biosimilars are expected to be particularly significant in the US MG market. s Zilbrysq (zilucoplan).
Biosimilars continue to build as a sector of this market with an estimated 2025 value in the region of US$42 billion (1). This covers new biotechnologically derived protein, glycoprotein, and peptide products as well as biosimilars (3, 4). Biosimilars Market Size | Industry Growth & Forecast Report. Specifications.
In February 2025, Teva and Alvotech have announced the US launch of the Selarsdi (ustekinumab-aekn) injection, a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). This targeted method could significantly improve patient outcomes across multiple oncology diseases. Sign up for our daily news round-up!
It has often been the leader in areas, such as the manufacture of generic drugs, over-the-counter medications, bulk drugs, vaccines, contract research and manufacturing, biosimilars, and biologics. Indian pharma is expected to touch the $65 billion mark by 2024.
Abbott’s pact focuses on localizing pharma manufacturing, biosimilar development, and advancing UAE’s digital health initiatives. BI’s OpnME platform access aims to enhance Abu Dhabi’s clinical research by providing compounds, networks, and collaboration tools.
Despite the removal of some of the most controversial proposals, the final rule still contains a variety of significant changes, which become effective on November 19, 2024. The term “drug product information” is now defined to include NDC, drug name, units per package size (UPPS), drug category (S, I, or N), unit type (e.g.,
Detect-A-Dose lid-label cover enhances medication recognition, reducing packaging errors through a contrasting visual pattern. 2 A prominent aspect of this issue that manufacturers have tried to tackle is medication recognition when transferring pills to containers and packaging. 1-3 Detect-A-Dose Lid Label Covers.
Telehealth platforms selling compounded GLP-1RAs flourished in 2023 and 2024 amid shortages of semaglutide and later tirzepatide. Eli Lilly’s Mounjaro generated 2024 sales of $11.5bn, whilst Novo’s Wegovy brought in approximately $8bn. Mochi Health is even the subject of a lawsuit initiated by Eli Lilly.
Karst We learned earlier this week that an allision (a runner-up to Merriam-Websters 2024 Word of the Year, polarization) may be poised to occurperhaps within a fortnight (another runner-up to Merriam-Websters 2024 Word of the Year thanks to Taylor Swift)as Congress considers various pieces of healthcare legislation as part of its year-end package.
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