News & Analysis as of

Biosimilars

CHMP Adopts Positive Opinions on BI’s CYLTEZO® and Samsung Bioepis’s ONTRUZANT®

by Goodwin on

On September 15, Boehringer Ingelheim (BI) and Samsung Bioepis each issued a press release announcing that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a...more

At The Bench: 2017 Mid-Year Case Review

Impression Prods. v. Lexmark Int’l, 137 S. Ct. 1523, 581 U.S. ___ (2017) The Supreme Court held that all patent rights are exhausted upon the first sale of a patented product, regardless of where the sale is made or...more

FDA Approves First Avastin Biosimilar

FDA announced Thursday that it has approved Mvasi (bevacizumab-awwb), Amgen and Allergan’s biosimilar of Genentech’s Avastin (bevacizumab), a monoclonal antibody used in the treatment of a number of different cancers. Mvasi...more

FDA Approves First Cancer-Treatment Biosimilar -- Amgen's Mvasi

Earlier on September 14, 2017, the U.S. Food and Drug Administration approved Amgen's application to market Mvasi (bevacizumab-awwb), a biosimilar to Genentech's Avastin therapeutic antibody for the treatment of multiple...more

The Biosimilars Council Supports Sandoz’s Preemption Position in Federal Circuit Amicus Brief

by Goodwin on

Last week the Biosimilars Council submitted an amicus brief in the Federal Circuit remand proceedings for Amgen v. Sandoz, arguing that Amgen’s state-law claims for Sandoz’s failure to comply with the patent dance’s...more

FDA Approves Amgen’s Biosimilar of Avastin®

by Goodwin on

Today, the FDA announced that it has approved Mvasi® (bevacizumab-awwb), Amgen’s biosimilar of Genentech’s Avastin®. According to the announcement, Mvasi® is the first biosimilar that the FDA has approved for the treatment of...more

Pharma and Biologic Disputes in Canada – New Regulations Take Effect September 21, 2017

by Bennett Jones LLP on

Pharma and biologics manufacturers will soon have big decisions to make regarding their pharmaceutical and biological product strategy in Canada. On September 6, 2017, the Governor General in Council, on recommendation of the...more

BI Files Answer to AbbVie’s Complaint in Adalimumab Litigation

by Goodwin on

As we previously reported, last month AbbVie filed a complaint against Boehringer Ingelheim (BI) in the U.S. District Court for the District of Delaware regarding BI’s aBLA for a biosimilar version of AbbVie’s Humira...more

Scheduling Order Entered in Janssen v. Samsung Bioepis

by Goodwin on

This morning, the district court in Janssen v. Samsung Bioepis, which concerns Samsung Bioepis’ Renflexis® (infliximab-abda) biosimilar product, entered a pretrial scheduling order. The scheduling order calls for, among other...more

Amgen/Allergan and Pfizer Present Positive Phase 3 Data For Two Investigational Trastuzumab Biosimilars

by Goodwin on

At the European Society for Medical Oncology (“ESMO”) 2017 Congress, which was held over the past several days in Madrid, Spain, companies presented Phase 3 clinical data regarding two investigational biosimilars of...more

FDA Accepts Applications for Rituximab and Filgrastim Biosimilar Candidates

by Goodwin on

According to press releases this week, the FDA has recently accepted two new Abbreviated Biologics License Applications (aBLA) for review. First, Adello Biologics yesterday announced that the FDA has accepted its aBLA for...more

Amgen v. Hospira: Litigation Update

by Goodwin on

With the September 18, 2017 trial date fast approaching, the district court in Amgen v. Hospira last week denied Hospira’s motion for summary judgment of non-infringement of its proposed biosimilar of Epogen®/Procrit®...more

Fresenius Kabi completes acquisition of Merck KGaA’s biosimilars business

by Goodwin on

Last week Fresenius Kabi announced that it has successfully closed its acquisition of Merck KGaA’s biosimilars business, which comprises Merck’s entire biosimilars development pipeline. According to Fresenius, the product...more

US FDA Delays Approval of Biocon and Mylan’s Biosimilar for Trastuzumab

by Goodwin on

As we’ve posted here, Biocon and Mylan are jointly developing a portfolio of biosimilars, including Fulphila (pegfilgrastim) and Ogivri (trastuzumab), and have filed applications for marketing authorization in the European...more

Amgen v. Apotex: Federal Circuit Oral Argument Set

by Goodwin on

The Federal Circuit has scheduled the oral argument of Amgen’s appeal from the district court’s judgment of non-infringement of Apotex’s proposed biosimilars of Neupogen® (filgrastim) and Neulasta® (pegfilgrastim) for 2:00pm...more

A road map to Life Sciences M&A in Germany

by Hogan Lovells on

U.S.-based life sciences companies considering transactions in Europe may easily become over-whelmed with the complexity of Europe’s various jurisdictions....more

Coherus Announces Positive Results for CHS-1420, Humira Biosimilar Candidate

by Goodwin on

Coherus reported that its proposed adalimumab (Humira) biosimilar candidate demonstrated clinical equivalence on all endpoints compared to the European marketed Humira. The candidate in this study also did not show any...more

Federal Circuit Provides More Guidance On Biosimilar Patent Litigation

by Foley & Lardner LLP on

In Amgen Inc. v. Hospira, Inc., the Federal Circuit held that Amgen could not obtain discovery related to activities that might infringe a patent that it had not asserted in its biosimilar patent litigation against Hospira....more

Janssen v. Celltrion: CAFC & District Court Litigation Update

by Goodwin on

As we previously reported last year, in the ongoing Janssen v. Celltrion litigation concerning Celltrion’s Inflectra®, a biosimilar of Janssen’s Remicade® (infliximab), Janssen appealed the district court’s partial final...more

FDA Approves Boehringer Ingelheim’s Adalimumab Biosimilar

by Goodwin on

Today, Boehringer Ingelheim received FDA approval for Cyltezo®, its biosimilar to AbbVie’s Humira® (adalimumab). Cyltezo® is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic...more

FDA, EU Regulators Agree to Share Unredacted Inspection Reports and Other Confidential Information

by Hogan Lovells on

The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the European Commission – DG Sante (DG Sante), signed a new confidentiality commitment which expands the scope of the current...more

Sandoz Files Petitions for IPR on Two Abbvie Adalimumab Patents

by Goodwin on

Sandoz has filed two petitions for IPR challenging Abbvie patents related to use of an antibody identified in the petitions as Humira® (adalimumab): IPR2017-01987 challenging U.S. Patent 8,911,737, directed to methods of...more

Sandoz Announces Erelzi Launch in Canada

by Goodwin on

Yesterday, Sandoz announced the launch of its etanercept product, Erelzi®, in Canada. Erelzi is a biosimilar to Amgen’s Enbrel®, and is approved for the treatment of moderately to severely active rheumatoid arthritis in...more

Deal Watch: Samsung Bioepis and Takeda Enter into Partnership

by Goodwin on

Samsung Bioepis announced that it has entered into a Strategic Collaboration Agreement with Takeda Pharmaceutical Company to co-develop novel biologic therapies in unmet disease areas. The companies’ first therapeutic...more

Ireland's Department of Health is Requesting Comments Regarding Its National Biosimilars Medicines Policy

by Goodwin on

Ireland’s Department of Health (the “Department”) recently reported on its website that it is “developing a National Biosimilar Medicines Policy to promote the use of biosimilar medicines and to create a sustainable...more

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