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- Biosimilars North America 2017
- Boehringer Ingelheim receives positive CHMP opinion for adalimumab biosimilar Cyltezo
- Samsung Bioepis received first positive CHMP opinion on a trastuzumab biosimilar
- Sandoz proposed biosimilar adalimumab matches reference biologic in terms of efficacy and safety in long-term study
- FDA has approved first Avastin biosimilar
- Biosimilars and Biobetters 2017 Conference
- Sandoz proposed biosimilar rituximab accepted for review by the FDA
- FDA accepts Adello Biologics’ biosimilar BLA for a filgrastim biosimilar candidate
- Pfizer presents positive pivotal data for Herceptin biosimilar at the ESMO 2017
- Biosimilar trastuzumab shown to be similar in efficacy and safety to Herceptin in breast cancer as neoadjuvant and adjuvant treatment
- Amgen and Allergan present Phase 3 data of their trastuzumab biosimilar at the ESMO 2017
- Cinfa Biotech reports clinical development data for pegfilgrastim biosimilar B12019 at ESMO 2017
- Boehringer Ingelheim receives FDA approval for Cyltezo, a biosimilar to Humira
- Samsung Bioepis first to receive EC approval for a third anti-TNF biosimilar
- Erelzi (etanercept biosimilar) is available in Canada for the treatment of multiple inflammatory diseases
- Sandoz etanercept biosimilar Erelzi receives positive reimbursement recommendation in Canada
- Amgen and Allergan submit biosimilar Biologics License Application for ABP 980 to US FDA
- Biosimilar Renflexis (infliximab) available on PBS from 1st August
- Biosimilar Market Access and Commercialization Strategies Summit
- Celltrion and Teva announce U.S. FDA acceptance of BLA for proposed biosimilar to Herceptin (trastuzumab)
- Boehringer Ingelheim starts clinical study on interchangeability between its adalimumab biosimilar candidate and Humira
- Pfizer announced positive results from the comparative study for PF-06439535, a potential biosimilar to Avastin
- World Biosimilar Congress Europe 2017
- Merck announces launch of Renflexis (Remicade biosimilar) in the United States
- Daiichi Sankyo discontinues etanercept biosimilar development in Japan
- Merck receives tentative approval for LUSDUNA Nexvue (insulin glargine injection) from FDA
- Long-term clinical outcomes after switching from Remicade to Remsima in IBD
- FDA Oncologic Drugs Advisory Committee unanimously recommends approval of Mylan and Biocon’s proposed biosimilar trastuzumab
- Amgen and Allergan to discuss data supporting BLA for ABP 215, bevacizumab biosimilar candidate
- Sandoz gains EU approval for biosimilar version of Roche’s MabThera
- FDA rejects Coherus’ biosimilar application for Amgen’s Neulasta
- Amgen and Allergan submit biosimilar biologics license application for ABP 215 to FDA
- Biosimilar trastuzumab, CT-P6, shown to be similar in efficacy and safety to the Herceptin
- Sandoz proposed biosimilars adalimumab and infliximab accepted for regulatory review by the European Medicines Agency
- FDA Advisory Committee recommends approval of Pfizer’s proposed biosimilar to Epogen/Procrit across all indications
- Sanofi receives CHMP recommendation for approval of Insulin Lispro biosimilar
- Cinfa Biotech announces positive top-line data from second clinical study with pegfilgrastim biosimilar candidate
- EMA published a new guideline on biosimilar medicines for healthcare professionals
- 8th Annual Biosimilars Asia Conference
- Glenmark’s omalizumab biosimilar candidate receives IND approval from FDA
- Celltrion agrees with Nippon Kayaku for rituximab biosimilar in Japan
- Celltrion applied for biosimilar trastuzumab in Japan
- Celltrion’s Truxima launched in Europe
- Fresenius Kabi acquires Akorn and Merck KGaA’s biosimilars in seperate deals
- Sandoz proposed biosimilars rituximab and etanercept recommended for approval in Europe
- FDA approves Renflexis, second infliximab biosimilar
- Alteogen to transfer biosimilar technology to Chinese partner
- Basaglar challenges Sanofi’s insulin drug Lantus in S.Korea
- China FDA accepts JHL’s first clinical trial application
- PDA Biosimilars Conference 2017
- EBE, EFPIA and IFPMA have today launched a position paper entitled “Considerations for physicians on switching decisions regarding biosimilars”
- New data demonstrate Sandoz proposed biosimilar adalimumab has equivalent efficacy to Humira
- Xbrane Biopharma reports positive in-vitro biosimilarity data on ranibizumab biosimilar
- Mundipharma to launch Truxima, the first rituximab biosimilar in seven European markets
- Celltrion’s biosimilar infliximab has positive results from pivotal study in Crohn’s Disease
- FDA accepts Mylan and Biocon’s proposed pegfilgrastim biosimilar for review
- New brand & campaign to expand access to medicines in the United States
- Aurobindo acquires four biosimilar products from TL Biopharmaceutical
- 9th Bi-Annual Biosimilars & Follow-On Biologics 2017 Americas
- Sandoz withdraws Zioxtenzo (pegfilgrastim) European application
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