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Food and Drug Administration (FDA) FDA Approval Fresenius

Goodwin

Denosumab Biosimilar Updates - June 2024

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On May 21, Alvotech announced that it had entered into a license and supply agreement with Dr. Reddy’s Laboratories SA for the commercialization of AVT03, a proposed denosumab biosimilar. Denosumab, sold by Amgen under the...more

Goodwin

Fresenius Kabi Announces FDA Approval of TYENNE, a Tocilizumab Biosimilar Referencing ACTEMRA

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​​​​​​​On March 7, Fresenius Kabi announced that the FDA has approved its tocilizumab biosimilar, TYENNE (tocilizumab-aazg) for inflammatory and immune diseases indications including rheumatoid arthritis, giant cell...more

Venable LLP

Fresenius Kabi’s Actemra® biosimilar Tyenne® (tocilizumab-aazg) Approved in the U.S.

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On March 5, 2024, the FDA approved Fresenius Kabi’s Tyenne® (tocilizumab-aazg) as a biosimilar of Chugai, Genentech and Hoffman-La Roche’s Actemra® (tocilizumab). ...more

Goodwin

Fresenius Kabi Announces FDA Approval of Adalimumab Biosimilar

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Earlier today, Fresenius Kabi announced that the U.S. Food and Drug Administration (FDA) approved IDACIO (adalimumab-aacf), a biosimilar referencing HUMIRA. IDACIO is approved for use in the treatment of chronic autoimmune...more

Goodwin

Fresenius Kabi Announces FDA Approval of Pegfilgrastim Biosimilar

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​​​​​​​On September 6, Fresenius Kabi announced that the U.S. Food and Drug Administration (FDA) approved STIMUFEND (pegfilgrastim), a biosimilar referencing NEULASTA, in patients with non-myeloid malignancies receiving...more

Kramer Levin Naftalis & Frankel LLP

Delaware Confirms the High Threshold for Material Adverse Effect Claims and Interprets ‘Commercially Reasonable Efforts’

A year after Akorn v. Fresenius (Akorn case), the first Delaware case holding that a party was entitled to terminate a merger agreement based on a material adverse effect (MAE), the Delaware Court of Chancery, in Channel...more

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