Tag: Biosimilars

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.

Biogen and Samsung Bioepis launch HUMIRA biosimilar in Europe

biosimilars
Biogen (USA) and Samsung Bioepis (South Korea) announced the European launch of IMRALDI (adalimumab), a biosimilar referencing HUMIRA. Starting today, IMRALDI will begin launching in major markets acr...

Amgen launches adalimumab biosimilar in Europe

molecule
Amgen announced that AMGEVITA, a biosimilar to adalimumab, to launch in markets across Europe. AMGEVITA is the first adalimumab biosimilar to be approved by the European Commission (EC).

EMA and European Commission published new information on biosimilars

biosimilars
The European Medicines Agency and the European Commission have published material on biosimilar medicines, as part of their collaboration to improve understanding of biosimilars.

Pall Biotech to collaborate with Aetos Biologics

biologics
Pall Corporation has announced a strategic partnership between its Pall Biotech business unit and Aetos Biologics, a biosimilar cell line development company.

GeneSys Biologics launches an integrated drug development facilty

biotech
GeneSys Biologics, an Indian biotechnology company based in Hyderabad, launched its integrated drug development facility in Genome Valley, Shameerpet (India).

BIOCAD’s biosimilar of darbepoetin alfa will be available at the end of 2018

BIOCAD
BIOCAD announced the completion of clinical trials for the first Russian-made biosimilar of darbepoetinalfa (BCD-066), which was designed to treat anemia related to chronic kidney disease or cancer.

Prestige BioPharma and Alvogen will launch Trastuzumab biosimilar in Europe

biosimilars
Prestige BioPharma and Alvogen announced that the two companies have entered into a binding agreement for the exclusive partnership and supply for the commercialization of Trastuzumab biosimilar in Central and Eastern Europe.