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55 articles with BioCon Limited
Mylan N.V. and Biocon Ltd. today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Ogivri®, a biosimilar to Roche's Herceptin® (trastuzumab).
In a brief statement, Mylan reported that the U.S. Food and Drug Administration (FDA) had informed the company that its Generic Advair Diskus had “minor deficiencies” that would be in a Complete Response Letter.
The U.S. Food and Drug Administration (FDA) approved Mylan’s Fulphila (pegfilgrastim-jmbd), a biosimilar to Amgen’s Neulasta (pegfilgrastim). The biosimilar was co-developed with Biocon.
U.S. FDA Approves Mylan and Biocon's Fulphila™ (pegfilgrastim-jmdb), the First Biosimilar to Neulasta®
Mylan N.V. and Biocon Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved Mylan's Fulphila™ (pegfilgrastim-jmbd).
Mylan and Biocon to Present New Data at the American Society of Clinical Oncology (ASCO) Annual Meeting Reinforcing the Efficacy, Safety and Immunogenicity of Ogivri™, the first biosimilar for Herceptin® approved by FDA
Mylan N.V. and Biocon Ltd. announced that 48-week results from the HERITAGE study will be presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting.
The FDA Giveth and Taketh Away: Grants Pfizer's MenB Breakthrough Therapy Designation and Turns D...
4/23/2018The FDA granted Pfizer’s Trumenba, a vaccine for meningococcal B disease in children ages one to nine years, Breakthrough Therapy Designation and declined to approve its biosimilar of Roche's Herceptin for breast cancer.
Mylan and Biocon Receive Approvals from the European Commission and TGA Australia for Semglee™, Biosimilar Insulin Glargine
Mylan N.V. and Biocon Ltd. announced that their co-developed biosimilar insulin glargine Semglee™ has received marketing authorization approval from the European Commission (EC).
The CHMP positive opinion will be considered by the European Commission. The European Commission decision on the approval is expected in April.
Both companies will share responsibility for end-to-end development, manufacturing and global regulatory approvals for a number of products, and will have a cost and profit share arrangement globally.
U.S. FDA Approves Mylan and Biocon's Ogivri, the First Biosimilar for Trastuzumab, for the Treatm...
12/1/2017Ogivri is the first FDA-approved biosimilar to Herceptin and the first biosimilar from Mylan and Biocon's joint portfolio approved in the U.S.
EMA acceptance of the submissions follows an earlier withdrawal of both applications in response to an audit conducted by the European inspecting authority of Biocon's drug product facility.
FDA Oncologic Drugs Advisory Committee Unanimously Recommends Approval Of Mylan And BioCon's Proposed Biosimilar Trastuzumab
Mylan And BioCon Present Clinical Data On Insulin Glargine At The American Diabetes Association's 77th Scientific Sessions
U.S. FDA Accepts Biologics License Application (BLA) For Mylan And BioCon's Proposed Biosimilar Pegfilgrastim For Review
Mylan Release: FDA Accepts Biologics License Application (BLA) For Pharma And BioCon's Proposed Biosimilar Trastuzumab
Mylan And BioCon Announce Regulatory Submission For Proposed Biosimilar Trastuzumab Accepted For Review By EMA
Mylan And BioCon Announce Regulatory Submission For Proposed Biosimilar Pegfilgrastim Accepted For Review By European Medicines Agency