June 17th 2025
With more than 100 next-generation biologics set to lose patent exclusivity in the next 15 years, there is widespread agreement that developing biosimilars for these therapies will benefit society as a whole.
May 29th 2025
Biocon Biologics’ Yesintek demonstrated comparable safety and efficacy to the originator project, according to clinical data from a trial program.
May 7th 2025
As more originator biologics lose patent exclusivity in the next decade, a healthy biosimilars pipeline is necessary but requires market support.
May 1st 2025
The bio/pharma industry is evolving with intention, intelligence, and a growing sense of shared purpose.
April 17th 2025
Celltrion’s adalimumab-aaty is designated interchangeable as a high-concentration (100mg/mL) and citrate-free formulation of adalimumab.
FDA Approves Amgen’s Avastin Biosimilar
The approval marks the first biosimilar approved in the United States for treating cancers.
EMA Recommends Approval of Herceptin Biosimilar
European Medicines Agency’s Committee for Medicinal Products for Human Use grants a positive opinion for the approval of the biosimilar for treating breast cancer.
Biocon Withdraws Breast Cancer Biosimilar Filings in Europe
The withdrawal has been attributed to issues at the biotech company’s manufacturing facility.
Analytical Strategy in the Development of Biosimilars
The author outlines an analytical strategy for establishing similarity in biosimilar development and approval.
FDA Accepts Application for Teva’s Herceptin Biosimilar
FDA advances biosimilars progress with acceptance of regulatory filing for biosimilar referencing a blockbuster biologic by Roche.
Biosimilars Overcome Legal and Analytical Hurdles
A Supreme Court decision and improvements in analytical processes may speed the biosimilar approval process.
Matching Tools to Biophysical Analysis Demands
Method choice is crucial to when seeking answers to biosimilar characterization questions.
Pricing Pressure Drives Down Drug Sales Forecasts
Drug sales forecasts fall for first time in 10 years, thanks to pressures to reduce drug prices and the advent of biosimilars.
FDA Acts to Improve Market Competition
The agency announced it is taking steps to increase competition within the prescription drug market.
EMA Recommends Approval for Eight New Drugs, One Biosimilar
The agency recommended approval of treatments for hepatitis C, cancer, multiple sclerosis, and arthritis.
Supreme Court Rules in Amgen v. Sandoz
The landmark decision determined that biosimilar makers can notify manufacturers before receiving FDA approval.
Gearing Up for Biosimilars
Contract manufacturers prepare for anticipated biosimilars manufacturing demands through expansion and acquisition.
EMA Promotes Understanding and Use of Biosimilars
EMA and the European Commission released a biosimilars information guide for health professionals during the EC’s biosimilars conference.
WHO Launches Biosimilar Pilot Program
The program aims to make biosimilars for the treatment of cancer more widely available in middle- and low-income countries.
Fresenius Kabi Acquires Merck KGaA’s Biosimilars Business
Fresenius Kabi enters biosimilars market with acquisition of Merck KGaA’s Biosimilars Business
FDA Approves Second Biosimilar to Remicade
The agency approved Renflexis, a biosimilar to Janssen’s blockbuster rheumatoid arthritis treatment.
EMA Suspends Drugs Associated with Micro Therapeutic Research Labs
The agency is recommending the suspension of a variety of medications because of unreliable bioequivalence studies conducted by Micro Therapeutic Research Labs
More Generic Drug Approvals Not Enough
Will new generic drugs bring the cost of medicines down in the way policy makers hope?
Biosimilar Names Prove Difficult to Define
A controversial naming convention attempts to explain important distinctions between biologic drugs and their biosimilar counterparts.
Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
Manufacturing for originator molecules is restricted by regulations, but drug makers can exploit newer technologies for the manufacture of biosimilars.
FDA’s Office of Generic Drugs Releases Annual Report
In 2016, FDA approved 630 ANDAs and tentatively approved 183 ANDAs, the highest number to date, according to the report.
EDQM Clarifies the Role of Monographs in Determining Biosimilarity
The directorate says monographs are flexible and changeable and their compliance does not on its own determine biosimilarity in biosimilars.
GPhA Rebrands as AAM
The Generic Pharmaceutical Association announces a rebranding campaign to expand access to medicines.
AbbVie: Despite Competition, Humira Still the Number-One Prescribed Biologic
Despite the threat of competition, both from biosimilars to Humira and new therapies that work through other mechanisms of action, AbbVie says Humira is still number one.
EMA Recommends Approval of Two Biosimilars
The agency recommended approval of a total of eight drugs at its January 2017 meeting, two of which are biosimilars.
Switching Studies Crucial to Demonstrate Biosimilar Interchangeability
FDA released a long-awaited draft guidance to help sponsors seeking to demonstrate interchangeability for biosimilar products.
FDA Guidance on Biosimilar Naming Receives Mixed Response from Industry
An FDA guidance on biosimilar naming garnered mixed responses from the Biosimilars Forum, the American College of Rheumatology, and Pfenex.
EMA Launches Biosimilars Project
A pilot project, beginning in 2017, will support the development of biosimilars.
Expression systems for the development of biosimilars
Andrew Bulpin, head of Process Solutions Strategic Marketing & Innovation at MilliporeSigma spoke with BioPharm International about the requirements of expression systems in biosimilar development.
Stimulating Biosimilar Uptake: Implications for Manufacturers
What will manufacturers have to do to ensure the continued uptake of biosimilars?