Tag: Biosimilars

ICMRA Issued Statement on Confidence in Biosimilars

biosimilars
The International Coalition of Medicines Regulatory Authorities (ICMRA) issued a new statement about confidence in biosimilar products. ICMRA present this statement on biosimilars to provide assura...

FDA Approved RUXIENCE™ for the Treatment of Patients with non-Hodgkin’s Lymphoma

pfizer
Pfizer Inc. announced the United States (U.S.) Food and Drug Administration (FDA) has approved RUXIENCE™ (rituximab-pvvr), a biosimilar to Rituxan® (rituximab), for the treatment of adult patients wit...

Amgen and Allergan Introduce Two Biosimilars in the U.S.

molecule
Amgen and Allergan announced that MVASI™ (bevacizumab-awwb), a biosimilar to Avastin® (bevacizumab), and KANJINTI™ (trastuzumab-anns), a biosimilar to Herceptin® (trastuzumab), are now available in th...

Mundipharma Acquire Rights to Tuznue from Prestige Biopharma

biosimilars
Mundipharma has picked up rights to Tuznue, a biosimilar of trastuzumab – Roche's Herceptin – from Singapore-based group Prestige Biopharma. The agreement allows the Mundipharma network to distribu...

EMA to Review MAA for First China-Developed Trastuzumab Biosimilar

First trastuzumab developed in China following the National Medical Products Administration (NMPA) technical guideline for biosimilar with the New Drug Application (NDA) received the acceptance for re...

Pfizer Received FDA Approval for Avastin® Biosimilar

Pfizer Inc. today announced the United States (U.S.) Food and Drug Administration (FDA) has approved ZIRABEV™ (bevacizumab-bvzr), a biosimilar to Avastin® (bevacizumab), for the treatment of five type...

Sandoz Announced Data from Phase III ADMYRA Trial of Bosimilar Hyrimoz

biosimilars
Sandoz, a Novartis division and a global leader in biosimilars, announced data from the Phase III ADMYRA trial demonstrating that the efficacy and safety of biosimilar Hyrimoz® (adalimumab) matches th...

Mundipharma Announced Exclusive Distribution Agreement for Pelmeg in CEE

biosimilars
Mundipharma has entered into the exclusive distribution agreement with Egis Pharmaceuticals for Pelmeg, a pegfilgrastim biosimilar treatment. The agreement covers Hungary, Romania, Latvia and Lithuani...

Manufacturers of Products Labeled as Homeopathic Received FDA Warning Letters

The U.S. Food and Drug Administration has posted warning letters to five companies who produce products labeled as homeopathic for significant violations of current good manufacturing practice (CGMP) ...

FDA Will Help Promote Competition in the Biologic Market

fda office
FDA is taking a significant action that will help promote competition in the biologic market by providing final guidance on the pathway for “interchangeable” biologics, which may be substituted witho...

Russian Drug Maker Gains World’s First Approval for Biosimilar Eculizumab

Russian drug manufacturer Generium Pharmaceutical, which specializes in orphan drugs, announced yesterday that it has received Russian marketing approval for its biosimilar eculizumab, referencing Sol...

Mundipharma Launches its Biosimilar in EU Countries

Mundipharma launches Pelmeg®▼(pegfilgrastim) biosimilar in Europe. It is now available in Germany, the Netherlands and Ireland. The Mundipharma network of independent associated companies has annou...

Alvotech Raised $300m for Biosimilars

Fuels growth and biosimilar development in a fast-growing market. Alvotech has successfully raised $300 million through a private bond offering. Net proceeds from the capital raised will be used to...

Fuji Pharma makes $50 million investment in Alvotech

biosimilars
Alvotech (Iceland), a biopharmaceutical company announced that Fuji Pharma (Japan) has acquired a 4.2% stake in the business for approximately $50 million.

Alvotech and Fuji Pharma signed an exclusive partnership agreement

clinical-trials
Alvotech (Iceland) and Fuji Pharma (Japan) announced that the two companies are entering into an exclusive partnership.

German Federal Minister of Health calls for faster deployment of biosomilars

biosimilars
Jens Spahn, Germany'sFederal Minister of Health of Germany, has stated in his recent interview that there should be faster uptake of biosimilars in Germany for cancer and autoimmune diseases.