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Comparator Sourcing Medizone – Splendid similarities – WorldPharma
Recent MEDIZONE article – WorldPharma – Clinical Trials Insight “Splendid similarities The benefits of biosimilars have long been championed in the medical sector, but with their use set to increase in...
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Medizone Campaign – Comparator Sourcing – Clinical Trials Insight
Opening up new dimensions in comparator sourcing for clinical trials. Being a pioneer means having a vision. Medizone as a strategic comparator sourcing partner for clinical trials and specialist for...
View ArticleFDA approves first biosimilar Zarxio (filgrastim-sndz) from Sandoz
Sandoz, a Novartis company, announced that the US Food and Drug Administration (FDA) approved Zarxio (filgrastim-sndz) for all indications included in the reference product’s label. Sandoz is the first...
View ArticleIntas launches Razumab, the first biosimilar to Lucentis
Intas Pharmaceuticals has launched Razumab™, its biosimilar to Lucentis® (Ranibizumab). Intas is the first company globally to develop and launch a biosimilar version of Ranibizumab. Razumab is...
View ArticleEpirus expands biosimilar pipeline and capabilities
Epirus Biopharmaceuticals, Inc., announced an agreement for the acquisition of Bioceros Holding B.V., enabling Epirus to expand its biosimilar pipeline and vertically integrate product development...
View ArticleCinfa Biotech treats first subjects in pegfilgrastim biosimilar clinical trial
Cinfa Biotech S.L., the biosimilars company of Infarco group, today announced that the first subjects have been dosed in a clinical trial of B12019, a biosimilar version of Neulasta(R) (pegfilgrastim)...
View ArticleSamsung Bioepis wins EMA nod for the first etanercept biosimilar in the...
Samsung Bioepis Co., Ltd. announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Benepali – a biosimilar version of...
View ArticleAmgen Biosimilars: First submission for Humira biosimilar in the United States
Amgen announced the submission of a Biologics License Application (BLA) with the United States FDA for ABP 501, a biosimilar candidate to Humira (adalimumab). Amgen believes this submission is the...
View ArticleFirst Etanercept biosimilar Benepali receives EU approval
The joint venture between Biogen and Samsung BioLogics, Samsung Bioepis, has been granted European Commission (EC) approval for Benepali, an etanercept biosimilar referencing Enbrel. Benepali® has been...
View ArticleBiocad announces the trastuzumab biosimilar approval in Russia
The trastuzumab biosimilar, to be marketed under the trade name HERtiCAD, is the first trastuzumab biosimilar to receive authorization from the Russian regulatory body. The market authorization of the...
View ArticleEMA accepts Sandoz’s pegfilgrastim submission
Sandoz, announced that EMA has accepted their Marketing Authorization Application for its biosimilar to Amgen’s EU-licensed Neulasta (pegfilgrastim) – a long-acting recombinant human granulocyte...
View ArticleFDA approves Inflectra, a biosimilar to Remicade
The U.S. Food and Drug Administration approved Inflectra (infliximab-dyyb) for multiple indications. Inflectra is administered by intravenous infusion. This is the second biosimilar approved by the...
View ArticleEpirus to sell CHO platform and biosimilar IP to Polpharma
As part of a cost-savings restructure, Epirus is selling the assets from its $14m acquisition of Bioceros last September to its biosimilars partner Polpharma. Last year , Epirus Biopharmaceuticals paid...
View ArticleCoherus BioSciences announces positive Phase III results for CHS-1420 (Humira...
Coherus BioSciences, Inc., reported topline results from an ongoing Phase 3 clinical study of CHS-1420, an adalimumab (Humira) biosimilar candidate. The study met its primary endpoint demonstrating...
View ArticleFDA approves Sandoz’ Enbrel Biosimilar
The U.S. Food and Drug Administration approved Erelzi, (etanercept-szzs) for multiple inflammatory diseases. Erelzi is a biosimilar to Enbrel (etanercept), which was originally licensed in 1998. The...
View ArticleMylan and Biocon filed the biosimilar Herceptin application to FDA
Mylan N.V. and Biocon Ltd. last week announced submission of Mylan’s biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, to the U.S. Food and Drug Administration (FDA)...
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Meet us at our booth at ARAB HEALTH 2017 – 30th Jan to 2nd Feb
We are looking forward to welcoming you at our booth at ARAB HEALTH – Stand No. Z3.E39 in the “German Hall”. 30th January to 2nd February 2017. For more information visit ARAB HEALTH exhibitor...
View ArticleSandoz proposed biosimilars rituximab and etanercept recommended for approval...
Sandoz, announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions, separately recommending the approval of both Sandoz’ biosimilar rituximab and biosimilar...
View ArticleCinfa Biotech announces positive top-line data from second clinical study...
Cinfa Biotech S.L., the biosimilars company of Cinfa Group, today announced positive top-line data from the second clinical trial with its lead development candidate B12019, a biosimilar version of...
View ArticleSandoz gains EU approval for biosimilar version of Roche’s MabThera
Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, announced that the European Commission (EC) has approved Rixathon (biosimilar rituximab) for use in Europe. Rixathon is...
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