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FDA Accepts Outlook Therapeutics’ BLA for Ophthalmic Bevacizumab

Outlook Therapeutics recently announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its Biologics License Application (BLA) for ONS-5010 / LYTENAVA (bevacizumab-vikg), an investigational...more

Issue 38: PTAB Trial Tracker

Fate of Fintiv - As discussed in our Client Alert, “Fintiv 2.0: USPTO Director Issues Guidance Softening Risk of Discretionary Denial,” USPTO Director Kathi Vidal issued a set of interim procedures clarifying how the PTAB...more

Lupin Announces Approval of ENBREL Biosimilar in Canada

​​​​​​​On September 13, 2022, Lupin Ltd. (“Lupin”) announced that its RYMTI product, a biosimilar to ENBREL (etanercept), has been approved in Canada. Lupin, based in Mumbai, India, specializes in cardiovascular, diabetic,...more

Supreme Court Cert Petitions on Skinny Label Inducement and Written Description Issues

On July 11, 2022, Teva filed a cert petition with the Supreme Court, seeking review of the Federal Circuit’s split per curiam opinion holding that Teva’s label for its generic drug Coreg induced doctors to infringe a GSK...more

U.S. Senators Request PTO Action on Patent Thickets

On June 8, 2022, a bipartisan group of U.S. Senators sent a letter to Kathi Vidal, Director of the U.S. Patent & Trademark Office, requesting that the PTO take action on patent thickets. According to the Senators, “large...more

Issue 37: PTAB Trial Tracker

Expert Testimony Alone Insufficient to Show Examiner's Material Error in Considering Prior Art - In Nespresso USA, Inc. v. K-fee System GmbH, IPR2021-01222, Paper 9, at 25 (PTAB Jan. 18, 2022), the Board denied...more

Formycon AG Acquires Biosimilar Assets Ustekinumab and Ranibuzumab

On May 10, 2022, Formycon AG (“Formycon”) and ATHOS KG (“ATHOS”) announced that they have closed a transaction regarding the biosimilar assets FYB201 (ustekinumab) and FYB202 (ranibuzumab). According to the press release,...more

Biosimilar Deal Watch: Formycon/ATHOS, Fresenius/mAbxience/Ivenix, and Intas/Axantia

It has been a busy last few weeks for biosimilar developers, with multiple deals announced. On March 29, 2022, it was announced that Formycon AG (“Formycon”) and ATHOS KG (“ATHOS”) have agreed to merge their development...more

FDA Accepts Alvotech’s BLA Supporting Interchangeability for ATV02, a High Concentration, Citrate-Free Biosimilar Candidate for...

Alvotech Holdings S.A. (“Alvotech”) announced on February 28th that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics Licensing Application (BLA) for ATV02 (100 mg/mL) that includes...more

Sandoz submits BLA for proposed biosimilar trastuzumab to the FDA

Last week, Sandoz announced that it submitted a Biologic License Application (BLA) for a proposed biosimilar trastuzumab (150 mg, for intravenous use) to the FDA. According to the press release, the biosimilar trastuzumab was...more

Coherus Announces FDA Approval of YUSIMRY (adalimumab-aqvh)

Today, Coherus BioSciences, Inc. announced that the FDA approved YUSIMRY (adalimumab-aqvh), a biosimilar of AbbVie’s HUMIRA product.  YUSIMRY is indicated for plaque psoriasis, psoriatic arthritis, rheumatoid arthritis,...more

Issue 36: PTAB Trial Tracker

FORUM SELECTION CLAUSES MAY OR MAY NOT PRECLUDE PTAB REVIEW - In Kannuu Pty Ltd. v. Samsung Electronics Co., Ltd. & Samsung Electronics America, Inc., No. 21-1638 (Fed. Cir. Oct. 7, 2021), the Federal Circuit considered...more

Ascletis and Suzhou Alphamab Expand their Partnership into Worldwide License Agreement for ASC22 (Envafolimab) to Treat Hepatitis...

Ascletis Pharma Inc. (Ascletis) and Suzhou Alphamab Co., Ltd. (Suzhou Alphamab) jointly announced that Ascletis’ subsidiary and Suzhou Alphamab have entered into an exclusive worldwide licensing agreement (excluding Greater...more

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