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Lupin, YL Biologics receive nod to market rheumatoid arthritis drug in Japan
expressbpd
March 27, 2019
Biosimilar Etanercept is indicated to treat moderate to severe rheumatoid arthritis (RA) and juvenile idiopathic arthritis
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The 1st Chinese-produced Biosimilar Approved for Marketing
PharmaSources/Yuntian
March 20, 2019
We would find out the reason if we looked into the situation of the original drug of rituximab
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FDA approves Trazimera (trastuzumab-qyyp), biosimilar to Herceptin
firstwordpharma
March 12, 2019
FDA today approved Trazimera (trastuzumab-qyyp), a biosimilar to U.S.-licensed Herceptin (trastuzumab).
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EU steps closer to generics and biosimilars manufacturing waiver
pharmaphorum
February 28, 2019
A change to European rules on drug manufacturing that could benefit makers of generics and biosimilars is edging closer, after lawmakers agreed draft legislation that tweaks rules on export and manufacture of drugs that are off-patent outside the EU.
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Selexis SA and Turgut Pharmaceuticals Expand Biosimilar Development Relationship by Signing Two Commercial License Agreements
pharmafocusasia
February 28, 2019
Selexis SA and Turgut Pharmaceuticals (Turgut Ilaclari A.S.) announced today that they have signed two commercial license agreements (CLAs) through which Turgut will leverage Selexis’ SUREtechnology Platform™ and ...
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Mundipharma Launches Pelmeg Biosimilar in Europe
americanpharmaceuticalreview
February 19, 2019
The Mundipharma network of independent associated companies announced the launch of Pelmeg (pegfilgrastim), a biosimilar of Neulasta following European Commission (EC) approval in November 2018.....
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Bio-macromolecular Drugs in the Autoimmune Disease Field in China
PharmaSources/1℃
February 13, 2019
Focus on the bio-macromolecular drugs in the autoimmune disease field that have been marketed or in the marketing review stage in China, overall, including 9 marketed drugs and 6 drugs in the marketing review.
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FDA approves Ontruzant (trastuzumab-dttb), 3rd biosimilar to Herceptin (trastuzumab)
firstwordpharma
January 21, 2019
FDA today approved Ontruzant (trastuzumab-dttb), a biosimilar to U.S.-licensed Herceptin (trastuzumab).
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Mycenax’s Actemra biosimilar edges closer to approval
pharmaphorum
January 02, 2019
Mycenax’s biosimilar of Roche’s Actemra (tocilizumab), LusiNEX, has been shown to match its originator’s profile in a phase I PK trial, meaning it is on track to become the first approved biosimilar for the drug.
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After New Year's, expect more drug pricing fireworks in 2019
pharmatimes
December 24, 2018
For several years, pharma watchers have witnessed drug pricing grow into a top issue facing the industry, dominating discussion almost daily.