Below are some recent updates regarding U.S. regulatory submissions and a launch in connection with biosimilar products: On September 27, 2018, Samsung Bioepis announced that the U.S. FDA has accepted its aBLA for SB5, a proposed biosimilar of Humira® (adalimumab), which Bioepis submitted to the FDA in July. According to…
Today, the PTO announced that it has published a final rule changing the claim construction standard applied during IPR, PGR, and CBM proceedings before the PTAB. The final rule replaces the “broadest reasonable interpretation” standard with the claim construction standard that is used to construe claims in civil actions in…
We have covered Pfizer’s development of biosimilars of Genentech’s Avastin® (bevacizumab) and Herceptin® (trastuzumab) and its related IPR filings IPR2016-01771 and IPR2016-01837. Following written decisions invalidating those two patents, Genentech appealed and challenged the constitutionality of subjecting patents that issued before the America Invents Act (AIA) was enacted in 2011…
On October 1, the Trump administration announced that it had secured a new trade agreement with Canada and Mexico. The United States-Mexico-Canada Agreement (USMCA) would replace the North American Free Trade Agreement (NAFTA), which has been in place since 1994. According to the White House press release, “[t]he new agreement includes…
On September 25, 2018, the House of Representative passed the “Patient Right to Know Drug Prices Act” (S.2554). As we previously reported, the Senate passed the bill on September 19, 2018. The bill includes amendments to the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (“MMA”) that require patent…
The Association for Accessible Medicines (AAM) and Biosimilars Council submitted comments to FDA two weeks ago regarding “the biosimilars action plan and ways to facilitate competition” in the biosimilars industry. Collectively referred to in the comments as AAM, and the “sole association representing America’s generic pharmaceutical sector in the United States,”…
In August, we reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the granting of marketing authorization for three biosimilar medicines: (1) Fujifilm Kyowa Kirin Biologics (FKB) and Mylan’s Hulio® (adalimumab), a proposed biosimilar of Humira®; (2) Accord Healthcare’s Pelgraz® (pegfilgrastim),…
Last week, FDA published its draft guidance on civil money penalties relating to the ClinicalTrials.gov data bank to the federal register. The guidance addresses how the FDA Centers (CDER, CBER, and CDRH, for drug, biological, and device products, respectively) identify whether parties have failed to submit required clinical trial registrations, results,…
As we previously reported, Pfizer filed a petition for IPR of certain claims of Hoffman-La Roche’s U.S. Patent No. 8,314,225 (IPR2018-01219). According to the petition, the challenged claims “purport to claim nucleic acid sequences that encode the C-terminal part of a human immunoglobulin heavy chain and a method for improving the expression…
We previously reported on discovery disputes in the adalimumab litigation between AbbVie and Boehringer Ingelheim (BI) pending before the District of Delaware. Earlier this month, Judge Lloret issued an order on additional discovery motions filed by the parties. Taking into account standards under the Federal Rules, “that the amount in controversy…