Biologics

News & Analysis as of

Legislation Tracker: PRICED Act Proposes to Shorten Biologic Exclusivity Period from 12 to 7 Years

A bill introduced in the House of Representatives yesterday proposes “[t]o amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 7 years.” Titled the “Price...more

Biosimilars: Supreme Court Calls for Solicitor General’s Views in Amgen v. Sandoz

On Monday, June 20, 2016, the Supreme Court deferred a decision on the certiorari petitions filed by both parties from the Federal Circuit’s decision in Amgen v. Sandoz, 794 F.3d 1347 (2015), and instead called for the views...more

The CREATE Act of 2016: Senate Listens to Generics Industry

Last week, co-sponsors Senators Leahy (D-VT), Grassley (R-IA), Klobucher (D-MN), and Lee (R-UT) introduced a bill (S. 3056), entitled the "Creating and Restoring Equal Access to Equivalent Samples Act of 2016" or the "CREATES...more

FDA Withdraws Previous Notice Seeking Comments on Proposed Biologic Naming Guidance

Earlier this month we reported that FDA had published a notice in the Federal Register soliciting comments on a proposed biologic naming guidance whereby applicants for biologic products would submit up to 10 proposed...more

Connecticut's New "Right to Try" Law Provides Hope for Patients and Providers, but FDA Remains in the Driver's Seat

Connecticut has recently joined the wave of states enacting a so-called “Right to Try” law, which ostensibly permits terminally ill patients access to investigational drugs (including biologics) and medical devices as a...more

Amgen v. Sandoz Update -- Supreme Court Seeks Views of United States

In other Supreme Court news from Monday, June 20, 2016, the Court invited the Solicitor General to file briefs in the Sandoz v. Amgen (No. 15-1039) and Amgen v. Sandoz (No. 15-1195) appeals to express the views of the United...more

Amgen v. Sandoz SCOTUS Appeal on Hold Until October

The Supreme Court on Monday called for the views of the Solicitor General regarding the petitions for certiorari filed by both parties in Amgen v. Sandoz. The case arose after Sandoz filed an aBLA for Zarxio®, a biosimilar of...more

FDA Issues Final Ruling Allowing Medical Device Manufacturers to Use Stand-Alone Symbols on Labels

This week, on June 14, 2016, the FDA issued a final ruling revising its medical device and certain biological product labeling regulations to allow, for the first time, manufacturers to use graphical representations of...more

Janssen Sues HyClone Laboratories Over Cell Cultures Used to Grow Celltrion’s Remicade Biosimilar

In the ongoing litigation over infliximab biosimilars, Janssen has filed two new complaints alleging infringement of claims in U.S. Patent No. 7,598,083: one against Celltrion and Hospira, and a second against HyClone...more

Merck’s Lantus Biosimilar Queued for an FDA Submission?

Merck, known as MSD outside the United States and Canada, announced promising results from two Phase III studies evaluating MK-1293 – Merck’s biosimilar to Lantus (insulin glargine). Lantus is used for the treatment of...more

Amgen v. Sandoz: Reply Briefs Submitted to Supreme Court

As we previously reported, on February 16, 2016, Sandoz petitioned the United States Supreme Court for a writ of certiorari regarding the Federal Circuit’s interpretation of the BPCIA’s “notice of commercial marketing”...more

Update on Naming Biosimilars

In August 2015, FDA released a long-awaited draft guidance for the nonproprietary names of biologics and biosimilars. The draft guidance recommends that nonproprietary names for biologic products should consist of the “core”...more

Arizona Passes Biosimilar Automatic Substitution Law

Last month, the governor of Arizona signed a bill into law allowing pharmacists to automatically substitute a biosimilar for a reference branded biologic. Arizona continues the recent trend of states enacting biosimilar...more

The (suf)Fix is In: FDA Opens the Floor for Comments on Biologic Naming Guidance

On June 2, 2016, the FDA filed a notice for comments on guidance requesting that biologic applicants propose a suffix composed of four lowercase letters for use as the distinguishing identifier included in the proper name...more

FDA Announces Closer Ties to WHO on Biologics

On May 31, 2016, the FDA issued a notice that FDA’s Center for Biologics Evaluation and Research (FDA/CBER) intends to “enhance technical collaboration and cooperation between the FDA, WHO, and its member states to facilitate...more

FDA issues guidance on the use of EHRs in clinical investigations

The U.S. Food and Drug Administration (FDA) just issued draft guidance on the Use of Electronic Health Record Data in Clinical Investigations for comment within the next 60 days. The guidance is intended to assist all...more

“Deemed to be a License” Provision Poses Potential Issues for Biological Products

The FDA recently requested comment on its draft guidance for implementation of the “deemed to be a license” provision as described in section 7002(e) of the Biologics Price Competition and Innovation Act of 2009 (“BPCI Act”)....more

Biosimilars in India News: Recent Guidelines from India’s CDSCO and a Pending Case on “Biosimilar” Trastuzumab

A recent court ruling and a new publication on guidelines for biosimilars in India may offer further guidance on what biosimilar and biologic stakeholders can expect from Indian regulatory authorities. In late March,...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On April 21, 2016, CMS issued a proposed rule entitled, “Medicare Program: FY 2017 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements.” This...more

FDA Biosimilars Guidance Not Conducive To Preemption

The FDA recently released draft guidance concerning the labeling of biosimilar products (analogous in the biologic context to generic drugs). It’s called, not surprisingly “Labeling for Biosimilar Products Guidance for...more

FDA Announces Approval of Second U.S. Biosimilar

On April 5, the FDA issued its approval for Inflectra, Celltrion and Pfizer’s biosimilar of Johnson & Johnson’s Remicade (infliximab). Inflectra is now the second biosimilar approved for sale in the United States, after...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On April 4, 2016, the Centers for Medicare & Medicaid Services (CMS) issued the Final Calendar Year (CY) 2017 Medicare Advantage Capitation Rates and Medicare Advantage (MA) and...more

CMS Proposes Testing Medicare Part B Drug Payment Reforms to Promote Value

CMS has released a complex and controversial plan – the Part B Drug Payment Model — to test new Medicare payment methods for certain Part B drugs to determine whether alternative payment designs will reduce Medicare...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...more

Senate HELP Committee Approves Additional Biomedical Innovation Bills

The Senate Health, Education, Labor and Pensions (HELP) Committee approved seven bills this month that are intended to promote biomedical innovation, building on legislation approved by the panel in February....more

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