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Celltrion and Hospira Move for Summary Judgment on the ’471 Patent in Janssen v. Celltrion

Defendants Celltrion and Hospira in Janssen v. Celltrion have moved for summary judgment that U.S. Patent No. 6,264,471, which covers Remicade (infliximab), is invalid for obviousness-type double patenting. At the District Court status conference earlier this month, Celltrion told the court that it expects FDA approval of its infliximab biosimilar product in…

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Biocon and Mylan Team Up for Biosimilar Regulatory Filings

Biocon, a prominent Indian biopharma company, entered into a partnership with Mylan in 2009 for joint research and development of biosimilars. That partnership now appears to be yielding results.  The companies expect to submit regulatory filings in both the U.S. and EU 2016: trastuzumab, pegfilgrastim, adalimumab, and insulin glargine. As Big…

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Big Day for Celltrion’s Infliximab Product

Yesterday, the FDA’s Advisory Committee overwhelmingly supported approval of Celltrion’s infliximab product, which is a biosimilar for Janssen’s Remicade product. At the District Court status conference in Janssen v. Celltrion, which followed the Advisory Committee vote, Celltrion’s counsel said that Celltrion is expecting FDA approval in about four to eight…

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FDA Scientists Express View that Celltrion’s Infliximab Biosimilar is "Highly Similar" to Remicade, Meet Today to Discuss Application

Following FDA support announced last Friday for Celltrion’s proposed Remicade® biosimilar (“CT-P13”), the FDA is holding an Advisory Committee meeting today to discuss Celltrion’s application. On Friday, the FDA said that based on its review of the data, Celltrion’s CT-P13 has been demonstrated to be highly similar to Remicade, notwithstanding…

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House Subcommittee on Health Addresses BPCIA Implementation and FDA Biosimilars Guidance

The House Energy & Commerce Committee’s Subcommittee on Health met this morning to discuss implementation of the Biologics Price Competition and Innovation Act. Sean Cavanaugh, Deputy Administrator and Director of the Center for Medicare, and Janet Woodcock, Director of the Center for Drug Evaluation and Research, testified. The subcommittee’s questioning…

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