Innovent Biologics Biosimilar Combination Surpasses Sorafenib in ORIENT-32
Bevacizuamb biosimilar in combination with sintilimab delivered significantly improved overall survival vs sorafenib.
Biosimilars Forum Chooses Director With Democratic Influence
Meaghan Rose Smith's appointment comes during a time of challenges for the biologics industry.
European Commission Approves Pfizer's Pegfilgrastim Biosimilar
Pfizer aims to begin marketing Nyvepria in the European Union in the first quarter of 2021.
The Top 5 Articles from ACR Convergence 2020
Here are the top 5 biosimilar articles from the American College of Rheumatology (ACR) Convergence 2020.
Opinion: Embrace the Era of Next-Generation Biologics
Bincy P. Abraham, MD, explains that even when payers allow coverage for biosimilars, providers may still be hesitant to use them.
Survey: Providers, Admins Struggle to Appreciate Biosimilar Suffixes
The FDA naming convention and its utility are not well understood, and “poor” biosimilar knowledge may be partly to blame, investigators report.
Alvotech Files for US and EU Approval of Adalimumab Biosimilar
The rheumatology and gastroenterology biosimilar candidate would enter the lucrative market established by Humira.
Samsung Biologics and AstraZeneca Dissolve Rituximab Partnership
Their rituximab biosimilar candidate was advancing in clinical trials for equivalence but represented a business conflict.
The Top 5 Biosimilar Articles for the Week of November 16
Here are the top 5 biosimilar articles for the week of November 16, 2020.
Fed Expert Describes Improving Regulatory, Policy Structure for Biosimilars
Prior to the turmoil of the pandemic, the FDA and CMS were at work on shoring up the biosimilars market, and this work continues on various fronts, a regulatory/policy expert explains.
Celltrion to Break Ground on Massive New Biopharmaceutical Plant
Plans for a $453.3 million high volume plant and research center were unveiled during an industry forum this week in Republic of Korea.
FDA Accepts Ranibizumab BLA From Samsung Bioepis and Biogen
The FDA's acceptance of the biologics license application (BLA) moves the companies one step closer to entering the US ophthalmology treatment sphere with a biosimilar.
Burich: Saving Grace for Biosimilars in 2021 Will Be Bipartisan Support
Despite a rocky power transition at the federal level, the compass heading for biosimilars is unchanged, said policy expert Molly Burich.
Genentech Files to Block Marketing of Centus' Bevacizumab Biosimilar
The reference product rights holder contends that Centus has not provided complete information about its manufacturing processes related to FKB238, the proposed biosimilar.
IGBA Launches Global Biosimilars Week
The International Generic and Biosimilar Medicines Association (IGBA) hopes to build momentum for the use of biosimilars.
High Adherence Noted Among Infliximab Biosimilar Users
Investigators looked at adherence in patients who switched from reference infliximab during treatment for rheumatologic and gastrointestinal treatment.
Biosimilars Poll: Which Way Will the Supreme Court Rule on the ACA?
The court must decide whether Congress’ setting the shared responsibility payment to $0 means that the entire Affordable Care Act (ACA) statute is now unconstitutional.
Prioritize Biosimilar Uptake in Europe, Conference Speaker Says
In Europe, the pandemic has revealed problems within health care systems and the need to increase access to biosimilars and reform health care policies.
Revance’s Botox Competitor Fails to Meet Efficacy End Point in Phase 2 Trial
Revance’s fight to compete in the onabotulinumtoxinA (Botox) market hit a snag when its drug candidate failed to meet the efficacy primary end point in a study.
US Rheumatologists Understand and Accept Biosimilars, but Some Hesitation Remains
The Top 5 Biosimilar Articles for the Week of November 9
Here are the top 5 biosimilar articles for the week of November 9, 2020.
Alvotech and Cipla Partner on 5 Biosimilars for South Africa
Alvotech and Cipla have joined forces to bring biosimilars to treat oncology and autoimmune diseases to South Africa.
Prestige Biopharma Licenses Trastuzumab Biosimilar to Teva Israel
Prestige Biopharma and Teva Israel join forces to bring a trastuzumab biosimilar to the Israeli market.
Samsung Bioepis’ Ranibizumab Candidate Shows Equivalence in Updated Results
Results up to week 52 in the phase 3 study show that primary end points were met for best corrected visual acuity and central subfield thickness.
Azar Says Trump's Drug Price Shake-up Is Working
HHS Secretary Alex M. Azar said efforts and policies to counter a sharply upward drug price trend have been successful, in a talk with the Association for Accessible Medicine.
Supreme Court Hints Biosimilar Route Might Be Preserved
The survival of the biosimilars approval pathway seemed on surer footing today following oral arguments at the Supreme Court over the Affordable Care Act and the severability of its provisions.
Samsung Launches Clinical Study of Denosumab Candidate
The company is targeting the lucrative osteoporosis market dominated by Prolia, an Amgen product.
OTBB Director Discusses FDA's Roadmap for Biosimilars
Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars (OTBB), highlighted the ways the FDA is working to remove blocks and wedges hindering biosimilars.
Multibiomarker Test Reads Out Positive in 2 Pfizer-Sponsored Studies
A multibiomarker disease activity score looks at serum protein activity for a more sensitive evaluation of biosimilarity, investigators said at the American College of Rheumatology Convergence 2020 meeting.
Goldman Sachs Bets Large on Biocon Biosimilars
Biocon Biologics nets a $150 million investment from Goldman Sachs to further its development and marketing of biosimilars.