On September 3, 2024, Eli Lilly filed a complaint against the FDA in the District Court for the Southern District of Indiana pursuing the latest challenge to the FDA’s application of its “biological product”...more
Health providers and consumers increasingly rely on the internet for health and medical-related information, but not all such information is reliable, and many statements are downright false. The proliferation of social media...more
The labeling of biosimilar products as “interchangeable” may be important in order to gain acceptance and use in the medical community. This article provides important information regarding revised FDA labeling guidance for...more
Could Help to Streamline Development and Approval - On May 25, 2023, the Food and Drug Administration (“FDA” or the “Agency”) announced the availability of a new Draft Guidance for Industry, Generally Accepted Scientific...more
On October 15, 2021, the U.S. Food and Drug Administration (“FDA”) approved Boehringer Ingelheim’s Cyltezo® (adalimumab-adbm), the first interchangeable biosimilar to AbbVie’s blockbuster immunosuppressant Humira®...more
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines hold promise to control the pandemic and help restore normal social and economic life, even as variant threats loom. ...more
Below is Alston & Bird’s Healthcare Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more
Key Points - In February, the U.S. Food and Drug Administration issued a "bright-line rule" redefining "biological products" under the Biologics Price Competition and Innovation Act (BPCIA) to include insulin and other...more
FDA authority to crack down on illegally marketed stem cell treatments confirmed - On Monday, a federal District Court in Florida issued a decisive blow against US Stem Cell Clinic, LLC, granting the U.S. Food and Drug...more
On December 19, 2017, FDA approved the gene therapy Luxturna (voretigene neparvovec-rzyl), developed by Spark Therapeutics, to treat children and adults with biallelic REP65 mutation-associated retinal dystrophy, an inherited...more
On January 17, 2017, the Food and Drug Administration (FDA) issued its long-awaited draft guidance on licensure as an interchangeable biological product approved under the Biologics Price Competition and Innovation Act of...more
On January 12, 2017, the FDA issued its final guidance on generic naming for biological products submitted pursuant to 351(a) or (k) of the Public Health Service Act. The guidance is titled Nonproprietary Naming for...more
The FDA broadly defines biologics as medical products derived from living sources (human, animal, plant, or microorganism) intended to treat or prevent diseases. Biologics thus include such varied vehicles of medical...more
This week, a high-profile FDA hearing sought to receive broad stakeholder input on four draft guidance documents from 2014 and early 2015 that further explain the agency’s views on some of the criteria for the regulation...more
Court says Congress has the power to make the change that HHS attempted with its Interpretive Rule, and thus it should be left to the legislative branch. A lawsuit challenging the Interpretive Rule, filed by the...more
On August 28, 2015, the Health Resources and Services Administration (“HRSA”) published proposed Omnibus Guidance (the “Proposed Guidance”) governing policies related to section 340B of the Public Health Service Act (“PHSA”),...more
The FDA has been gradually issuing guidances to implement the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). One of the most eagerly awaited guidance documents has been that on nonproprietary names to be...more
Biosimilars Are Generally Treated as Single Source Drugs - On March 30, 2015, in the wake of the first biosimilar product licensed by the Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services...more
Life sciences companies seeking protection for their biological products gain clarity on the submission procedures and standards of evaluation for reference product exclusivity requests. As the Food and Drug...more
On September 9, 2014, the U.S. Food and Drug Administration (“FDA”) published the first edition of the Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or...more
In recent months, as the conversation about reforming the health care system has shifted to achieving greater delivery system efficiencies, cost containment, and patient satisfaction, the role of health care...more
On August 5th, the U.S. Food and Drug Administration issued a "Guidance for Industry" entitled "Reference Product Exclusivity for Biological Products file under Section 351(a) of the PHS Act." Before setting forth the first...more