News & Analysis as of


Pfizer Receives Complete Response Letter from FDA for Trastuzumab aBLA

by Goodwin on

Today, Pfizer announced that it received a Complete Response Letter (CRL) from the FDA in response to Pfizer’s application for its proposed biosimilar of Herceptin® (trastuzumab). According to Pfizer’s press release, the CRL...more

Judge Sleet Grants Amgen’s Motion To Dismiss Genetech’s Commercial Marketing Claim Without Prejudice

by Fox Rothschild LLP on

By Memorandum Opinion entered by The Honorable Gregory M. Sleet in Genentech, Inc. et al. v. Amgen Inc., Civil Action No. 17-1407-GMS (D.Del. April 17, 2018), the Court granted defendant Amgen’s motion to dismiss the claim of...more

Mylan Partners with Fujifilm Kyowa Kirin Biologics

by Goodwin on

Last week, Fujifilm Kyowa Kirin Biologics (FKB) and Mylan announced that they will partner with one another to commercialize in Europe FKB327, a biosimilar of adalimumab developed by FKB. As we previously reported, the...more

FDA Releases Five-Year Plans for User Fee Programs

by Goodwin on

Pursuant to the five year reauthorization of FDA’s user fee programs for prescription drugs, generic drugs, and biosimilars, FDA recently released its five-year financial plans (2018-2022) for the programs. The plans...more

Celltrion Moves for Summary Judgment in Janssen v. Celltrion

by Goodwin on

Last week, in the ongoing Janssen v. Celltrion litigation concerning Celltrion’s Inflectra®, a biosimilar of Janssen’s Remicade® (infliximab), Judge Wolf of the U.S. District Court for the District of Massachusetts granted...more

USP States That It Will Not Revise Biologics Monographs Without Stakeholder Consensus

by Goodwin on

USP stated last week that it will not develop new product-specific monographs for biologics without stakeholder consensus in supporting their creation, including the support of FDA. USP had proposed revisions for these...more

Amgen v. Adello: A Blind Biosimilar Infringement Lawsuit

Last month, Amgen sued Adello Biologics, a US-based biosimilar maker, for patent infringement under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) in connection with Adello’s proposed biosimilar of Amgen’s...more

Win or Go Home? Standing to Appeal PTAB Decisions Upholding Patentability to the Federal Circuit Before Submitting a Biosimilar...

Biosimilar developers have been aggressive in filing petitions for inter partes reviews (IPRs) of biologics patents before the Patent Trial and Appeal Board (PTAB), many of them preceding the filing of a marketing...more

CMS releases Medicare Advantage/Part D final rule

by Hogan Lovells on

On April 2, 2018, the Centers for Medicare & Medicaid Services (CMS) released a final rule to revise regulations and clarify program requirements within the Medicare Advantage (MA) and the Prescription Drug Benefit (Part D)...more

Commissioner Gottlieb Addresses Biosimilars at Conference

by Goodwin on

At CNBC’s Healthy Returns conference last week, FDA commissioner Scott Gottlieb discussed plans to encourage competition and speed approval of biosimilars. His comments largely tracked a statement that he made in early March....more

AbbVie and Samsung Bioepis Announce Global Settlement of Adalimumab Disputes

by Goodwin on

Today, AbbVie and Samsung Bioepis announced that they have reached a global resolution of all intellectual property-related litigation relating to Samsung Bioepis’ biosimilar of Humira® (adalimumab), SB5, clearing the way for...more

LG Chem Tests LBEC0101, a Biosimilar to Enbrel (etanercept), in Rheumatoid Arthritis

by Goodwin on

The results of a Phase III study of LBEC0101, a biosimilar to Enbrel (etanercept) developed by Korean pharmaceutical company LG Chem, have been published. The study evaluated the similarities between LBEC0101 and the...more

Life sciences and health care horizons - March 2018

by Hogan Lovells on

Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more

Wisconsin and West Virginia Pass Biosimilar Legislation

by Goodwin on

Last week, both Wisconsin and West Virginia passed legislation intended to facilitate the dispensing and substitution of biosimilar products. Wisconsin and West Virginia join Michigan, which enacted House Bill 4472 on...more

FDA Comments on USP Proposed Revisions to Biologics Monographs

by Goodwin on

In a letter sent on Wednesday, March 28, 2018, to the CEO of the United States Pharmacopeial Convention, FDA’s Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research, and Dr. Janet Woodcock, Director of...more

Recent Biosimilar Industry Coverage

by Goodwin on

A number of media sources have covered new developments in the biosimilars space. Here is a round-up of some highlights from this month....more

Update on Biosimilar Launches and Development

by Goodwin on

Biocon announced yesterday that it has received marketing authorization approval from the European Commission for Semglee™ (insulin glargine). The decision came after receiving a positive recommendation by the Committee for...more

UK Parliamentary Committee Publishes Life Sciences Brexit Negotiation Recommendations

by Hogan Lovells on

The UK House of Commons Health and Social Care Committee has published the findings of its six-month long investigation into the impact of Brexit on medicines, medical devices and substances of human origin. ...more

Filgrastim and Pegfilgrastim Litigation Updates

by Goodwin on

Over the past several weeks, there have been numerous developments in U.S. patent litigation activity relating to biosimilars of Neupogen® (filgrastim) and Neulasta® (pegfilgrastim). Below is a summary of these developments....more

Amgen/Allergan & Sandoz Receive Positive CHMP Opinions

by Goodwin on

Last week the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) recommended two biosimilar medicines for approval. First, the CHMP adopted a positive opinion for the marketing...more

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

Health Care Weekly Preview from ML Strategies – March 2018 #3

This is the week. Congress needs to fund the government by Friday to avoid a government shutdown. It’s all but certain that the government will be funded, despite the dysfunction on display in getting through this week. The...more

AAM Publishes White Paper on Need for Increased Access to Biosimilars

by Goodwin on

A recent white paper from the Association for Accessible Medicines (AAM) highlighted the continued need to lower prescription drug prices. According to the paper, up to half of all patients fail to adhere to their medication...more

Innovation In Hatch-Waxman And ANDA Litigation

by Seyfarth Shaw LLP on

The Hatch-Waxman Act was enacted in 1984 to address two main congressional goals: (1) to encourage innovation in pharmaceutical research and development; and (2) to help generic drugs reach the market more quickly. Through...more

Merck Launches Ontruzant®, First Trastuzumab Biosimilar in Europe

by Goodwin on

Last week it was reported (here and here) that Merck launched Samsung Bioepis’ Ontruzant® in the United Kingdom, the first biosimilar trastuzumab launched in Europe. Ontruzant® is a biosimilar of Roche’s Herceptin® and is...more

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