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President Trump’s executive orders and legislative proposals from Congress leverage FDA to help lower drug prices, address anti-competitive practices, and accelerate generic drug approvals....more
Welcome to the latest issue of Blockbuster Biologics Review, which covers the status and developments of post-grant challenges and patent litigations implicating blockbuster biologics and legislative proposals related to...more
On March 17, 2025, Senators Chuck Grassley (R-IA), John Cornyn (R-TX), Richard Blumenthal (D-CT), and Richard Durbin (D-IL) re-introduced the “Affordable Prescriptions for Patients Act” (“APPA”), which previously passed the...more
The bipartisan legislative push could create big hurdles for drug development, with concerns mounting over limited patent protections and increased litigation risks, hears Marisa Woutersen. The US pharmaceutical industry...more
A Senate panel has advanced three sets of bipartisan bills purportedly aimed at reforming the intellectual property (IP) landscape and lowering the cost of prescription drugs. Together, these bills seek to address issues with...more
On July 10, the Senate unanimously passed the Affordable Prescriptions for Patients Act of 2023 (S.150), which seeks to increase competition and lower drug prices by imposing limits on patent litigation related to biological...more
The Situation: Senate Bill 150 ("S.B. 150")—the Affordable Prescriptions for Patients Act of 2023—unanimously passed the Senate and would amend 35 U.S.C. § 272(e) to limit, under certain circumstances, the number of patents...more
The Cozen Lens - While it’s becoming ever clearer Vice President Harris is likely to be the Democratic nominee following President Biden’s decision to step aside, it’s less clear what the impact will be on the presidential...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
Biosimilars are becoming increasingly important in healthcare as they offer a lower-cost alternative to biologic drugs, which can be expensive for patients, governments, and insurers. These biologic medicines, which are...more
On November 17, 2022, Senator Mike Lee (R-UT) introduced the “Biosimilar Red Tape Elimination Act” to increase biosimilar competition and reduce patient costs by prohibiting the FDA from requiring switching studies to approve...more
Henrik Ibsen's 1882 play, An Enemy of the People, engendered an aphorism having a longer lifetime than the play itself (except amongst the literati) which is unfortunate, because the play has some lessons about human nature...more
As we close out another calendar year, we look back at the top legal developments of 2021 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district...more
On July 13, 2021, the Senate Judiciary Committee’s antitrust panel met to discuss biologic and biosimilar competition and its impact on drug prices. A group of senators, led by Senator Amy Klobuchar, are sponsors of a Senate...more
On April 23, 2021, Congressmen Schrader and Kinzinger introduced H.R. 2815, the Bolstering Innovative Option to Save Immediately on Medicines Act (“BIOSIM Act”). The bill provides for temporary increased reimbursement to...more
On July 23, 2018, Congressman John Sarbanes (D-Md.) introduced a bipartisan bill, the Biosimilars Competition Act of 2018, meant to curb “pay-for-delay” agreements entered into by biologic and biosimilar drug manufacturers....more
Senator Orrin Hatch (R-UT) recently introduced a bill titled the “Hatch-Waxman Integrity Act of 2018” (HWIA). Sen. Hatch suggests that the HWIA will (i) “restore the careful balance the Hatch-Waxman Act struck to incentivize...more
Last month we reported that Vermont, Connecticut, New Hampshire, and Alaska were in the process of considering biosimilar substitution bills. Vermont and Connecticut recently enacted their respective bills....more
After a committee hearing on the price of rheumatoid arthritis drugs last week, Senator Susan Collins (R-ME) announced that she is working on a bill designed to lower drug costs. According to Bloomberg Law, the aim of the...more
The House and Senate Committees released a draft bill on Friday to reauthorize user fee programs for biosimilars, pharmaceuticals, generic drugs, and medical devices from 2018 to 2022. The bill states that the fees authorized...more
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
Although the 12-year exclusivity period for original biologic products was a heavily negotiated provision of the Biologics Price Competition and Innovation Act (BPCIA), increased spending on biologic drugs has led to calls to...more
Following months of public outcry and Congressional probes into significant drug price increases, the Senate Judiciary Committee introduced legislation targeting “behavior that blocks competition and delays the creation of...more
Back in March, 2016, the Senate added language to the FDA and NIH Workforce Authorities Modernization Act which would exempt biological products, including biosimilars, from provisions of the FDCA Act that require compliance...more
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