News & Analysis as of

Biologics License Applications

King & Spalding

FDA’s Much Anticipated New Cell and Gene Therapy Guidance Outlines a Conservative Approach to Manufacturing Changes

King & Spalding on

Biologics have long been defined by their processes, raising complicated questions about how to assess the effect of manufacturing changes on product quality—i.e., whether pre- and post-change products are comparable. This...more

Proskauer - Life Sciences

BridgeBio Transaction Reflects Healthy Market for FDA Priority Review Vouchers

BridgeBio’s recently announced sale of an FDA Priority Review Voucher for $110 million reflects a robust secondary market for these regulatory fast passes. Prices for Priority Review Voucher (“PRVs”) reflect the high stakes...more

Rothwell, Figg, Ernst & Manbeck, P.C.

FDA Accepts Bio-Thera’s BLA for Bevacizumab Biosimilar

On January 28, 2021, Bio-Thera Solutions, Ltd., a biopharmaceutical company based in China, announced that the U.S. Food and Drug Administration (FDA) accepted its Biologics License Application (BLA) for BAT1706, a proposed...more

Rothwell, Figg, Ernst & Manbeck, P.C.

FDA Accepts Review of Samsung Bioepis and Biogen’s Ranibizumab Biosimilar

On November 18, 2020, companies Samsung Bioepis Co., Ltd. and Biogen Inc. announced that the United States Food and Drug Administration (“FDA”) accepted for review the Biologics License Application for SB11, a proposed...more

MoFo Life Sciences

Pediatric Exclusivity For Biologics

MoFo Life Sciences on

The U.S. Food and Drug Administration’s six-month pediatric exclusivity rules that apply to drugs also largely apply to biologics (albeit with certain distinctions), which may become a valuable life cycle management strategy...more

Fish & Richardson

How Biosimilars Are Approved and Litigated: Patent Dance Timeline

Fish & Richardson on

A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an FDA-approved reference biological product. Biosimilar applicants have a number of choices to make on the path...more

Akin Gump Strauss Hauer & Feld LLP

Delaware Court Recommends Dismissal with Prejudice of Biosimilar Neulasta Suit

In a Report and Recommendation issued December 7, 2017, Magistrate Judge Burke in the District of Delaware recommended that Amgen’s BPCIA complaint for infringement against Coherus Biosciences Inc. be dismissed with prejudice...more

Goodwin

FDA Seeks Comments on Evaluation of Proposed New Model for Reviewing BLAs

Goodwin on

The FDA announced that it is soliciting public comments on the statement of work for the assessment of its proposed new model for the review of original Biologics License Applications submitted under section 351(k) of the...more

Foley & Lardner LLP

Industry Perspectives On The Biosimilar Patent Dance

Foley & Lardner LLP on

The Supreme Court could issue its decision in the Amgen v. Sandoz biosimilar patent dance case any day now. Last week I participated in a panel discussion with industry stakeholders considering how the decision might–or might...more

Knobbe Martens

Supreme Court Grants Certiorari in Amgen v. Sandoz

Knobbe Martens on

On January 13, 2017, the Supreme Court granted certiorari in Amgen v. Sandoz, 794. F.3d 1347 (Fed. Cir. 2015) and Sandoz v. Amgen, 773 F.3d 1274 (Fed. Cir. 2014), appealed from the Federal Circuit. The petitions involve the...more

Kramer Levin Naftalis & Frankel LLP

Supreme Court to Consider Biologics Price Competition and Innovation Act

On Friday, Jan. 13, the Supreme Court granted the appellant’s petition and the respondent’s cross-petition for a writ of certiorari in Sandoz Inc. v. Amgen Inc. This is the first time the Court will construe the Biologics...more

Patterson Belknap Webb & Tyler LLP

Supreme Court Grants Cert in Amgen v. Sandoz

On January 13, 2017, the Supreme Court granted Sandoz’s petition for certiorari and Amgen’s cross-petition in Amgen v. Sandoz, case nos. 15-1039 and 15-1195. The two cases were consolidated, and an hour was allotted for oral...more

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