- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
The Top 5 Biosimilar Articles for the Week of January 4
Here are the top 5 biosimilar articles for the week of January 4, 2021.
Number 5: China’s National Medical Products Administration (NMPA) has approved Innovent Biologics’ adalimumab biosimilar (Sunlino) for new indications.
Number 4: Providers should feel confident using Mvasi, a bevacizumab biosimilar, for all indications of the reference product (Avastin), reviewers stated.
Number 3: Product differentiation by concentration is a threat to the multiple adalimumab biosimilars approved but not yet launched.
Number 2: Alvotech has moved forward with expansion of its Reykjavik, Iceland, facilities to speed up development and put the company on its way to launching its first biosimilars.
Number 1: A study of uptake of the trastuzumab biosimilar ABP 980 (Kanjinti) in Europe found strong uptake patterns, according to an abstract presentation at the 2020 San Antonio Breast Cancer Symposium.
To read all of these articles and more, visit centerforbiosimilars.com.
FDA and Industry Experts Unpack Biosimilar Device Requirements
October 23rd 2024At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Unifying Standards: The Need for Streamlined Biosimilar Development
October 22nd 2024At the 2024 GRx+Biosims conference, industry leaders and regulatory experts underscored the urgency of unifying global standards and simplifying the biosimilar development process, sharing insights on recent advancements and the necessity for greater collaboration between manufacturers and regulatory agencies.
Phase 3 Study Reports Similar Efficacy Between SB17, Stelara in Psoriasis
October 19th 2024A phase 3, 28-week comparative clinical trial in patients with moderate to severe plaque psoriasis confirmed similarity of the proposed ustekinumab biosimilar SB17 (Samsung Bioepis) to the reference product (Stelara) in efficacy, safety, pharmacokinetics, and immunogenicity.
