As we close out another calendar year, we look back at the top legal developments of 2020 that could influence the market for biologics and biosimilars. While there were a number of case-specific decisions this past year that, undeniably, impacted the availability of biosimilars in the market, the five legal…
On December 27, the President signed the Consolidated Appropriations Act, which includes two provisions relevant to biosimilars: First, Section 322 of Division BB permits but does not require aBLAs to include information to show that the biosimilar’s conditions of use are the same as conditions of use approved for the…
In passing H.R. 1865, the Further Consolidated Appropriations Act, 2020 (“FCAA”), on December 20, 2019, Congress adopted a number of changes to the BPCIA that impact biosimilars. Under the BPCIA, approved NDAs for biological products will be “deemed to be a license” as if approved under BLAs as of March…
This month, the Star Ratings for Biosimilars Act was introduced in the House. H.R. 4629 is a bipartisan bill that requires the U.S. Department of Health and Human Services (HHS) to evaluate Medicare Advantage (MA) plans based on whether biosimilars are available to enrollees, and adds “a new set of…
On July 31, the U.S. Department of Health and Human Services (HHS) announced a Safe Importation Action Plan (“Action Plan”) created with the Food and Drug Administration (FDA) to “allow the importation of certain prescription drugs originally intended for foreign markets,” particularly Canada. According to the HHS Secretary Alex Azar, “[the…
On June 27, 2019, the Senate Judiciary Committee voted to advance four bills, summarized below, to the Senate floor. Senate Judiciary Committee Chairman Lindsey Graham issued a statement that the bills “each in their own way will lower the cost of prescription drugs.” S. 1227, the Prescription Pricing for the…
On June 11, Representatives Hakeem Jeffries (D-New York) and Doug Collins (R-Georgia) introduced a bipartisan bill with the stated purpose of addressing the rising cost of prescription drugs. According to the press release, the “Terminating the Extension of Rights Misappropriated (TERM) Act of 2019,” H.R. 3199, would “significantly limit[] the…
The U.S. House of Representatives unanimously passed two bills yesterday, H.R. 1520 (Purple Book Continuity Act of 2019) and H.R. 1503 (Orange Book Transparency Act of 2019). The Purple Book Continuity Act of 2019 would require the Purple Book to publish lists of patents associated with approved biological products, but…
On June 13, Senator Orrin Hatch (R-UT), co-author of the Drug Price Competition and Patent Term Restoration Act (aka the “Hatch-Waxman Act”), proposed an amendment in the Senate Judiciary Committee to modify the inter partes review (IPR) process for pharmaceuticals. The amendment, titled the Hatch-Waxman Integrity Act of 2018, would require aBLA…
Following up on our prior reports, last week President Trump signed into law the “Patient Right to Know Drug Prices Act” (S.2554). Among other changes, the bill amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to require that Reference Product Sponsors and biosimilar applicants file patent settlement agreements…