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Biologics New Legislation

McDermott Will & Emery

Special Report - 2022 FDA Year in Review

As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more

Fish & Richardson

Biosimilars 2021 Year in Review

Fish & Richardson on

2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more

Hogan Lovells

New Orange & Purple Book laws increase transparency of patent information for drugs, biologics

Hogan Lovells on

On January 5, 2021, President Trump signed into law H.R. 1503, the "Orange Book Transparency Act of 2020," which amends provisions governing the types of patents and exclusivity-related information for approved drugs listed...more

McDermott Will & Emery

An Early Holiday Present for Generics? Legislation Requiring Greater Disclosure by Brands Passes the Senate

McDermott Will & Emery on

Earlier this month, two bills intended to promote generic competitiveness by presenting a clearer idea of the patent landscape covering reference products passed the full Senate, albeit with amendments. These laws, if...more

Shumaker, Loop & Kendrick, LLP

Client Alert: Update on Florida’s Canadian Prescription Drug Importation Program

This year, Florida Governor Ron DeSantis signed into law a bill that creates Florida Statute Section 381.02035, which establishes the Canadian Prescription Drug Importation Program within the Agency for Health Care...more

Wilson Sonsini Goodrich & Rosati

Sitting Here on Capitol Hill: Congressional Developments on Life Science and Consumer Product Issues - July 2019 #2

Legislation - Consumer Product Safety: House Committee Approves Six Bills - Responding to what they claim has been a failure of the Consumer Product Safety Commission (CPSC) to act in recent years, the House Energy and...more

Wilson Sonsini Goodrich & Rosati

Sitting Here on Capitol Hill: Congressional Developments on Life Science and Consumer Product Issues - July 2019

Legislation - Biologics: Senate Health Committee Passes Bipartisan Legislation to Lower Health Care Costs - During the last week of June, the Senate Health, Education, Labor, and Pensions (HELP) Committee approved...more

Smart & Biggar

Canada introduces Bill C-100: A step towards ratification of “NAFTA 2.0”

Smart & Biggar on

In a step towards ratifying the Canada-United States-Mexico Agreement (CUSMA), the Canadian government introduced Bill C-100, entitled “An Act to implement the Agreement between Canada, the United States of America and the...more

Smart & Biggar

Contrasts and Distinctions: Canadian Patent Law Developments in 2018

Smart & Biggar on

2018 served up a smorgasbord of disparate patent law developments in Canada. Most notably, ratification of a new trade agreement negotiated amongst Canada, the United States and Mexico would require introduction of a patent...more

Mintz - Health Care Viewpoints

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

Goodwin

Arizona Passes Biosimilar Automatic Substitution Law

Goodwin on

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

Mintz - Health Care Viewpoints

California Becomes Latest State to Pass Biosimilar Substitution Law

On October 6th, California’s governor signed Senate Bill 671, which permits pharmacists to substitute an interchangeable biological product for a prescribed biological product. The California legislature had attempted to pass...more

Polsinelli

Medical Innovation: Congressional Committees Support Accelerated Research and Development for New Drugs, Devices and Biologics

Polsinelli on

Recent hearings by Senate and House committees and a scheduled markup underscore Congress' continued commitment to eliminating barriers that are slowing the development of effective drugs, devices, and biologics so that...more

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