Tag: Biosimilars

Agreement to Commercialize in the U.S. and Canada a Biosimilar Candidate to Lucentis

Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc., has entered into an exclusive licensing agreement with STADA Arzneimittel AG and its development partner, Xbrane Bi...

Teva and Celltrion Announce the Launch in the U.S. of Biosimilar to Rituximab for Rheumatoid Arthrit...

Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and Celltrion Healthcare, Co., Ltd., announced that TRUXIMA® (rituximab-abbs) injection is now available in the...

Biocon and Mylan Launch Biosimilar Neulasta in Canada

Biocon and Mylan NV have jointly launched Fulphila, a biosimilar to Neulasta (pegfilgrastim), in Canada for cancer patients. Fulphila, which was launched in Australia two weeks ago, is approved by ...

Richter and Mycenax Entered into an Asset Purchase Agreement of Biosimilar Tocilizumab

Gedeon Richter Plc. announced that it has entered into an asset purchase agreement with Mycenax Biotech Inc. in respect of biosimilar tocilizumab for the treatment of rheumatoid arthritis. ​Accordi...

The FDA Will Approve Biosimilars via a New Regulatory Pathway

Today (March 23, 2020) is a historic day and a landmark moment for patients with diabetes and other serious medical conditions, as insulin and certain other biologic drugs transition to a different re...

Ten drugs have potential to reach blockbuster status by 2025

Out of all the drugs that are currently in the pre-registration phase and are expected to launch in 2020, ten have the potential to reach blockbuster status over the next six years, according to Globa...

Next Steps to Ensure Smooth Regulatory Transition of Insulin Products

The U.S. Food and Drug Administration took additional steps to ensure a smooth regulatory transition aimed at increasing patient access to insulin products used daily by millions of Americans to maint...

Growth PsA Market will Mainly be Driven by the Launch of Five New Pipeline Agents

The psoriatic arthritis (PsA) market was valued at $4.7bn in 2018 across the seven major markets (7MM*), and it is expected to grow to $9.3bn by 2028 at a compound annual growth rate (CAGR) of 7.0% ac...

Pfizer Brings Three New Biosimilars to U.S. Patients at Substantial Discounts

Pfizer will become the first company to bring three oncology monoclonal antibody (mAb) biosimilar treatments to the U.S. market Pfizer announced that it is introducing three new biosimilars, ZIRABEV™ ...

WHO Prequalified First Own Biosimilar

who
The World Health Organization (WHO) announced it has prequalified its first biosimilar, a year and a half after it invited manufacturers to submit applications for prequalifying biosimilars to two bio...

FDA Made Statement on Low-Cost Biosimilars

biosimilars
Ensuring an efficient pathway to bring potentially lower-cost biosimilar and interchangeable protein products to market is key for expanding access to these products and increasing competition, ultima...

EC and UK OECD Stressed Importance of Generics and Biosimilars for Healthcare Systems

A joint report has been issued by the European Commission (EC) and the UK Organisation for Economic Co-operation and Development (OECD) on healthcare in the EU, highlighting the importance of generics...

Yas Holding Signed Agreement for Exclusive Partnership and Supply of Alvotech Biosimilars

UAE
Biopharmaceutical company Alvotech announced that Abu Dhabi-based investment company, Yas Holding, has acquired a 2.5% stake in their business and signed an agreement for the exclusive partnership and...

FDA Approved Fifth Biosimilar to Humira

biosimilars
The U.S. Food and Drug Administration (FDA) approved Abrilada (adalimumab-afzb), the 5th biosimilar to U.S.-licensed Humira (adalimumab). This approval marks the 25th biosimilar. A biosimilar is a ...

FDA Approved ABRILADA™, biosimilar to Humira®

pfizer
Pfizer Inc. announced the United States (U.S.) Food and Drug Administration (FDA) has approved ABRILADA™ (adalimumab-afzb), as a biosimilar to Humira® (adalimumab), for the treatment of certain patien...

Teva and Celltrion Announced Availability of TRUXIMA® in the U.S.

celltrion
Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd., Celltrion, Inc., and Celltrion Healthcare, Co., Ltd. announced that TRUXIMA® (rituximab-abbs) injection is the ...