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The Top 5 Biosimilar Articles for the Week of June 19
Here are the top 5 biosimilar articles for the week of June 19, 2023.
Hi, I’m Justina Petrullo for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.
Here are the top 5 biosimilar articles for the week of June 19th, 2023.
Number 5: Sarfaraz K. Niazi, PhD, examined the new FDA guideline that acts as an invitation to biosimilar developers to decrease the cost of testing, potentially opening the door for companies to reduce nonclinical testing of biosimilars entirely.
Number 4: A survey of patients with rheumatoid arthritis found that those who had switched to an adalimumab biosimilar reported higher disease severity, poorer treatment adherence, and poorer quality of life compared with patients who stayed on the reference product, highlighting the dangers of the nocebo effect.
Number 3: After 8 years of trastuzumab biosimilar competition and slow uptake, a new report showed that trastuzumab biosimilar discounts from the reference product (Herceptin) doubled between 2019 and 2022.
Number 2: SmithRx became the first pharmacy benefit manager (PBM) to announce it will cover Yusimry, 1 of 9 FDA-approved adalimumab biosimilars; Celltrion Healthcare received a thumbs-up from the FDA to test a biosimilar for Ocrevus; Alvotech and Teva Pharmaceuticals settled with Johnson & Johnson over their biosimilar referencing Stelara.
Number 1: Coherus Biosciences and AbbVie agreed to resolve a dispute regarding Coherus’ partnership with the Mark Cuban Cost Plus Drug Company and an adalimumab biosimilar, and Celltrion and Bio-Thera Solutions expanded their respective partnerships to include more biosimilar products.
To read all of these articles and more, visit centerforbiosimilars.com.
Eye on Pharma: Korean Drugmakers’ Impact in Europe; New Denosumab, Eculizumab Deals
January 11th 2025Korean drugmakers hold over 50% market share in the 6 best-selling biosimilar markets, 2 companies sign exclusive licensing partnership for a denosumab biosimilar, and 2 others join forces for an eculizumab biosimilar.
Biosimilars Gastroenterology Roundup for November 2024—Podcast Edition
December 1st 2024On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.
Equivalence Confirmed: CT-P41 Paves the Way for Affordable Osteoporosis Care
January 8th 2025Celltrion’s denosumab biosimilar demonstrated equivalent efficacy, safety, and immunogenicity compared with the originator in a phase 3 trial involving postmenopausal women with osteoporosis, paving the way for improved accessibility and cost savings in osteoporosis treatment.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Study Confirms CT-P42 Therapeutic Equivalence to Reference Aflibercept in DME
January 6th 2025The phase 3 trial showed biosimilar CT-P42 (Celltrion) is therapeutically equivalent to reference aflibercept in improving visual acuity in patients with diabetic macular edema (DME), with comparable efficacy, safety, pharmacokinetics, and immunogenicity at 24 weeks, with more long-term data expected.
