News & Analysis as of

Biologics

New State Substitution Laws, and a Busy Spring for Biosimilars

We recently updated our chart that tracks state biosimilar substitution laws to include new laws in Iowa and Montana. These new laws bring the total number of states with biosimilar substitution laws to 27, plus Puerto Rico....more

Cures Corner: FDA Launches Regenerative Medicine Advanced Therapy Designation Program

by Jones Day on

In late January 2017, FDA took the first steps to implement certain provisions of the 21st Century Cures Act ("Act"), signed into law on December 13, 2016, by launching a new designation program for regenerative medicine...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 1

As 2017 began, FDA appeared poised to implement significant changes to the rules governing off-label communications related to drugs, biologics, and medical devices. The Agency had hosted a public hearing in November 2016 to...more

Genentech and Roche Secure FDA Approval of Multiple Sclerosis Drug Ocrevus

On March 28, 2017, the U.S. Food and Drug Administration (FDA) approved the use of Ocrevus (ocrelizumab) in treating multiple sclerosis (MS). Ocrevus is a new biologic and is the first drug approved by the FDA to treat...more

China’s FDA Accepts JHL Biotech’s Clinical Trial Application for Rituximab Biosimilar in NHL

by Goodwin on

JHL Biotech announced today that China’s FDA has accepted its application for the use of JHL1101 in Phase 1 and Phase 3 clinical trials in non-Hodgkin’s lymphoma patients. JHL1101 is a rituximab biosimilar candidate that JHL...more

Trends in Life Sciences: From Data Protection to Drug Pricing

As part of our series on current trends across different industries, we explore current changes taking place in the life sciences field. Privacy & Data Protection - Personal information protection and compliance...more

Amgen Obtains FDA Priority Review for BLINCYTO (blinatumomab)

by Goodwin on

Amgen announced last week that the FDA has granted priority review for a supplemental BLA for BLINCYTO (blinatumomab). BLINCYTO received approval in 2014 for Philadelphia chromosome-negative relapsed or refractory B-cell...more

Orphan Drug Designation

“Orphan drug” is a designation given to certain pharmaceutical and biological products (drugs) that would likely not be developed due to a relatively small patient population and limited potential for profitability. In the...more

AbbVie’s Humira is the first to receive FDA approval for fingernail psoriasis

by Goodwin on

Today, AbbVie announced that the F.D.A. approved the inclusion of moderate to severe fingernail psoriasis data in the HUMIRA® (adalimumab) prescribing information for patients with moderate to severe chronic plaque psoriasis....more

PTAB Institutes IPR of Genentech’s Bevacizumab Patent

by Goodwin on

The PTAB has instituted inter partes review of Genentech’s U.S. Patent 7,622,115, granting Hospira’s petition in IPR2016-01771. According to the institution decision, the patent is directed to methods for treating cancer in...more

PTAB Institutes IPR in Hospira’s Challenge to Genentech’s Trastuzumab Patent

by Goodwin on

The PTAB has instituted IPR2016-01837, in which Hospira challenges Genentech’s U.S. Patent 7,807,799. The institution decision extends to all challenged claims, claims 1-3 and 5-11. ...more

Celltrion Files Petitions for IPR of Three Rituximab Patents

by Goodwin on

Celltrion has filed three petitions for IPR of Biogen’s patents related to rituximab: IPR2017-01093, challenging U.S. Patent 8,329,172; IPR2017-01094 challenging U.S. Patent 8,557,244; and IPR2017-01095 challenging U.S....more

FDA Accepts Alexion Pharmaceuticals’s SOLIRIS® (Eculizumab) Supplemental Biologics License Application for Refractory Generalized...

by Goodwin on

Connecticut-based Alexion Pharmaceuticals, Inc. announced today that the FDA has accepted its supplemental Biologics License Application (sBLA) for SOLIRIS® (eculizumab) as a potential treatment for patients with refractory...more

Republican Healthcare Bill Would Leave BPCIA Untouched

In public debates over the Affordable Care Act (ACA), also known as Obamacare, biosimilars are rarely, if ever, mentioned. But the U.S. biosimilar statute, the Biologics Price Competition and Innovation Act (BPCIA), was in...more

New Mexico Senate Passes Bill Allowing Automatic Substitution of Interchangeable Biologics

by Goodwin on

Last week, the New Mexico Senate passed a bill that would amend New Mexico’s existing automatic substitution law for small molecule drugs to allow “a pharmacist to dispense any one of the … interchangeable biological products...more

SCOTUS to Weigh In on Two Biosimilar Patents, Provisions of the BPCIA in 2017

2017 is shaping up to be a big year for biosimilars and for the Biologics Price Competition and Innovation Act of 2009 (BPCIA) specifically. The Supreme Court is scheduled to hear oral arguments on April 26, 2017, that will...more

Will You, Won't You Join The Biosimilar Patent Dance?

by Foley & Lardner LLP on

In the latest dispute surrounding the “patent dance” provisions of the Biologics Price Competition and Innovation Act (BPCIA), Genentech, Inc. has filed a complaint against Amgen, Inc., alleging that after opting into the...more

Combination Products: Regulatory and Patent Issues You Should Consider Now

Originally published in Pharmaceutical Technology - February 23, 2017. Products involving combinations of drugs, biological products, and medical devices are becoming increasingly prominent. Combination products can...more

Hurdles for Neulasta Biosimilars

A number of biosimilar makers have tried to obtain approval for proposed biosimilar versions of Amgen’s Neulasta (pegfilgrastim), a long-acting version of Amgen’s Neupogen (filgrastim), but have encountered hurdles so far...more

FDA 2016 Year in Review

by McDermott Will & Emery on

The enactment of the 21st Century Cures Act signaled the close of a multi-year bipartisan effort on Capitol Hill to grant the US Food and Drug Administration (FDA) new authorities to expedite product development and reform...more

More Than 25% of New Molecular Entities Approved in 2016 Are Personalized Medicines

by Foley & Lardner LLP on

The Personalized Medicine Coalition (PMC) recently reported that for the third year in a row, personalized medicines accounted for more than 25% of all new molecular entities (NMEs) approved by the US Food & Drug...more

[Webinar] Biologics and Biosimilars: Development with an Eye Towards FDA Approval - February 17th, 10:00am PST/1:00pm EST

In January 2017, the U.S. Food and Drug Administration (FDA) released a highly anticipated draft guidance detailing the agency’s expectations for demonstrating biosimilar interchangeability with a reference product and final...more

FDA Issues Draft Guidance on Demonstrating Interchangeability Under the BPCIA

by McCarter & English, LLP on

On January 17, 2017, the Food and Drug Administration (FDA) issued its long-awaited draft guidance on licensure as an interchangeable biological product approved under the Biologics Price Competition and Innovation Act of...more

FDA Final Guidance on Nonproprietary Names of Biological Products

by Fish & Richardson on

In January, 2017, the FDA released a final guidance document outlining its rules for giving nonproprietary names to biological products. The issue has been controversial, since unlike with a generic version of a traditional...more

Inflectra® Biosimilar Patent Litigation—The Remedies Dispute

by Fish & Richardson on

A pending patent-infringement case, litigated under the Biologics Price Competition and Innovation Act (“BPCIA”), will present several new questions related to how the BPCIA will interact with patents on biosimilar...more

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