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.
Rapid Assessment of Molecular Similarity between a Candidate Biosimilar and an Innovator Monoclonal Antibody Using Complementary LC–MS Methods
Intact protein LC–MS detected a mass variance of 62 Da and peptide mapping located a difference of two amino acids.
Five Things Every Biotech Company Must Know About Biosimilars
The new US legislation will forever alter the commercial landscape for biologics.
The New Normal
New R&D models must be tried, but it will take time to see if they work. In the meantime, a new kind of threat is on the horizon: biobetters.
Moving Toward a Biosimilars Pathway: The Lines are Drawn in Congress
The introduction of two rival bills has intensified the long-simmering debate on biosimilars regulation in the US.
Book Review: Biopharmaceutical Products in the US and European Markets 6th edition (2 volumes)
The book is a useful, comprehensive, and truly an excellent reference source of biopharmaceutical information.
Biopharmaceuticals in India: Evolving from Generics to Innovator Drugs
The new patent regime is challenging the Indian biopharm industry to transition from generics to novel products.
Understanding India's New Patent Laws
Did the 2005 Patents Act engender a Western intellectual property rights culture in the country?
Biologics Regulation in India
India is restructuring its regulation of biopharmaceuticals to help the country's industry compete internationally.
Creating Affordable Vaccines for India
How an electronics engineer led the first Indian company to carry out indigenous development of a recombinant vaccine.
The Role of Analytical Science in the Debate over Biosimilars
Both innovator and generics companies are using analytics to support comparability arguments.
Indian Biogenerics: An Evolving Industry
Indian biogenerics could form a major piece of the global biotherapeutics market in the future.
What Follow-on Biologics Mean for the Future of the Biotechnology Industry
The industry needs a clear regulatory pathway for the approval of biosimilars.
Protein Therapeutics and the Regulation of Quality: A Brief History
Regulatory agencies have evolved along with the biotechnology industry to define quality standards.
Biotech Manufacturers Face Competition from "Similar" Follow-Ons
The main testing and regulatory provisions of the FOB legislation reflect multiple trade-offs between the demands of innovators and generics firms.
US Congress Acts on Follow-On Biologics and FDA Funding
In late June and early July, the US Congress moved forward on three important bills affecting the biopharmaceutical industry, related to follow-on biologics, the Prescription Drug User Fee Act (PDUFA), and the 2008 FDA budget.
Regulatory Beat: Campaign Accelerates for Follow-on Biologics
The information provided by analytical testing is important in determining whether additional clinical trails are necessary to bring a follow-on to market.
Regulatory Beat: Campaign Heats Up for Follow-On Biologics
The prospect of any cost savings has been fueling efforts to establish a pathway for follow-on biopharmaceuticals.
Legal Forum: Patenting Strategies to Delay Biogeneric Competition
In the US, the patent term is 20 years from the filing date . . . commercial product may lose patent protection just as sales are ramping up.
Final Word: Omnitrope's Approval: What Does It Mean For Other Generics?
Congress is not considering legislation that would expand FDA authority to regulate biologics.
Final Word: The US is Falling Behind on Generic Biopharmaceuticals
Without generic competition, the US is at risk of losing its position of leadership in biopharmaceuticals.
The Best Targets for Biogenerics
Of all the protein products on the US market, at most 75 are likely to become genericized.