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. The latest version of our chart can be found here. As with the laws we’ve seen before, both the Iowa and Montana biosimilar amendments mirror the state’s existing generic drug substitution laws. More specifically, they amend state pharmacy laws to allow, and in some situations require, the substitution of interchangeable biosimilars. Continue Reading New State Substitution Laws, and a Busy Spring for Biosimilars
Sarah Beth S. Kuyers is an Associate in the Health Law Practice and is based in the firm’s Washington, DC office. She advises health care providers, pharmacy benefit managers, and laboratories on regulatory issues. She is admitted to practice in Virginia and is practicing under the supervision and guidance of Members in the DC office. Before joining the firm, Sarah Beth was a law clerk with the health staff of the Senate Committee on Finance, where her research focused on commercial insurance reform, health IT, Medicare, Medicaid, and the Affordable Care Act.
As we’ve previously discussed on Health Law and Policy Matters, agencies within the Department of Health and Human Services (DHHS) pushed through several final rules towards the end of the Obama Administration (see here and here). However, since taking office, President Trump has followed through on his campaign promise to significantly roll back Federal regulations and has taken several actions aimed at slowing and reversing agency regulatory processes, including processes at the DHHS sub-agencies CMS and FDA. These executive actions are creating a climate of uncertainty for regulated industries and their stakeholders. Continue Reading Trump Executive Orders Create Uncertainty for Health Care & Pharmaceutical Industries
As reported on the Privacy and Security Matters blog last week, the Mintz Levin privacy team recently updated the “Mintz Matrix,” a summary of the U.S. state data breach notification laws that we update on a quarterly basis, or more frequently as needed. In addition to HIPAA, health care organizations must remain aware of the separate state notification obligations and other privacy and security laws when responding to data breaches. The Mintz Matrix is available here.
The U.S. Department of Health and Human Services, Office for Civil Rights (OCR) recently announced the first ever settlement related to a Covered Entity’s untimely breach notification in violation of HIPAA. Presence Health, a health care network in Illinois, discovered a breach of unsecured personal health information (PHI) on October 22, 2013. After reporting the breach to OCR over three months later on January 31, 2014, OCR determined that Presence Health failed to notify OCR, each of the affected individuals, and prominent media outlets of the breach without unreasonable delay and within 60 days of learning of the breach, as required of Covered Entities under HIPAA. The violation resulted in a $475,000 settlement between OCR and Presence Health.
On Tuesday, President Obama signed the 21st Century Cures Act (the “Act”) into law. The Act is a massive piece of legislation that has implications for many different aspects of the interconnected medical research, product development, and health care delivery enterprises. Our colleagues have previously discussed the Act’s many provisions that aim to speed up the process of bringing new drugs and devices to market. One of the Act’s most significant amendments to the Federal Food, Drug and Cosmetic Act will allow FDA to grant accelerated approval to regenerative medicine products, while also providing the Agency with wide discretion on creating new approaches to regenerative medicine. This legislative development is historic given increasing pressure from patients and other stakeholders to move regenerative medicine advancements more quickly from the lab into the clinic. Continue Reading President Obama Signs 21st Century Cures Act; Creates Accelerated Approval Pathway for Regenerative Medicine
In non-election news, the Office for Civil Rights (OCR) at the Department of Health and Human Services recently released its November Cyber Awareness Newsletter. This month’s newsletter focuses on the topic of authentication. OCR encouraged health care companies to review and strengthen their authentication methods and other safeguards to avoid breaches of electronic protected health information (ePHI).
Although National Cyber Security Month isn’t until October, September has brought plenty of privacy and security updates that health care companies need to be aware of. In this post, we review guidance from the Office for Civil Rights (OCR) on cyberattacks, describe new state breach notification laws, and highlight the upcoming NIST/OCR security conference. Continue Reading September Privacy and Security Updates
As we predicted in yesterday’s post, FDA approved a new biosimilar product, Sandoz’s Erelzi (etanercept-szzs), which is a biosimilar to Amgen’s Enbrel (etanercept), on August 30th. FDA’s decision comes shortly after its Arthritis Advisory Committee voted unanimously in support of approving the biosimilar. FDA followed its draft naming guidance and assigned the biosimilar’s non-proprietary name using the reference product’s drug substance name followed by a nonsense four-letter suffix. Erelzi becomes the third biosimilar to receive FDA approval (the second for Novartis subsidiary Sandoz) and is indicated for rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis, similar to Enbrel. However, Erelzi cannot be launched commercially until at least 6 months after Sandoz provides Amgen with the mandatory notice required under the law, which the Federal Circuit Court of Appeals has affirmed cannot be provided until after FDA approves the biosimilar application.
UPDATE (August 31, 2016): Shortly after we published this blog post, FDA approved Sandoz’s biosimilar to Amgen’s Enbrel (etanercept), called Erelzi (etanercept-szzs). Erelzi becomes the third biosimilar to receive FDA approval (the second for Novartis subsidiary Sandoz) and is indicated for rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis, similar to Enbrel.
In a sign of growing scientific acceptance and understanding of the biosimilar regulatory pathway, FDA’s Arthritis Advisory Committee (AAC) voted unanimously last month in favor of approving two new biosimilar products – GP2015, Sandoz’s biosimilar to Amgen’s Enbrel (etanercept); and ABP 501, Amgen’s biosimilar to Abbvie’s Humira (adalimumab). If approved, both biosimilars would be labeled to reduce inflammation in patients with autoimmune diseases, such as rheumatoid arthritis.
After reviewing data from analytical, pre-clinical, and clinical trials demonstrating that the proposed biosimilars are “highly similar” to their respective reference products, the AAC recommended that FDA approve each of the two abbreviated biologics license applications (aBLAs). The committee also voted that the totality of the evidence presented by each biosimilar sponsor supported extrapolation of those data to all of the reference products’ currently approved indications.
Last week, the Centers for Medicare and Medicaid Services (CMS) released its proposed rule for the Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgical Center (ASC) Payment System for 2017. CMS proposed several new policies in the rule, including the implementation of Section 603 of the Bipartisan Budget Act of 2015 (BBA). Section 603 requires certain items or services provided by off-campus outpatient departments or “provider-based departments” (PBDs) to no longer be paid under OPPS but rather under the “applicable payment system.” The proposed rule provides only limited exceptions to this requirement, much to hospitals’ dismay.