MedicalTechnologies_Tubes2We 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

As our regular readers know, we’ve been tracking regulatory approvals, reimbursement policies, pharmacy substitution laws, and other developments related to biosimilar biological products. Biosimilars rely on the safety and efficacy history of an existing biological product for FDA approval by demonstrating that the biosimilar is “highly similar” to the reference product.  Recent weeks have been busy ones for state and federal officials involved in this area, and certainly the same can be said for developers of biosimilar products who need to keep pace with these rapid developments.

State Substitution Laws

As the 2016 State Legislative Session enters full swing (indeed, a few regular sessions have already adjourned for the year), we expect that more states will join Puerto Rico and the nearly 20 states that have enacted new laws or regulations specific to biosimilar substitution and dispensing as of the end of last year.  According to a recent tally by the National Conference of State Legislatures, at least 10 bills related to biosimilars (either newly filed or carried over from 2015) are pending this spring, many of which are very similar to laws already in effect in other states.

We are reporting that the “pending bills” number is 10 rather than 11, as the NCSL currently indicates, because the Kentucky legislature has joined several of its neighbors (Illinois, Indiana, Tennessee, and Virginia) in overwhelmingly approving an automatic biosimilar substitution law.  On March 29th, the bill was delivered to the Governor for signing, which he is expected to do.   Continue Reading Biosimilar Developments Continue at a Rapid Pace

Our Biosimilar webinar series continued this month with Linda Bentley and Joanne Hawana’s Biosimilars FDA/Regulatory Overview presentation. Linda and Joanne discussed statutory provisions related to FDA’s authority to approve biosimilar products, as well as FDA guidance on demonstrating biosimilarity, biosimilar product development and user fees, “interchangeable” biosimilars, biosimilar product labeling and naming, and reference product and biosimilar exclusivity.

For those who missed the webinar, some of the key takeaways include the following: Continue Reading ICYMI: Biosimilars and FDA Regulatory Webinar

After months of pressure from industry, health practitioners and even congressional stakeholders, FDA has finally proposed a convention for assigning nonproprietary names (also known as proper names) to biological products. The Agency published notice of its draft guidance on August 28th in the Federal Register, along with a proposed rule to assign new proper names to some already approved biologic products, including the only biosimilar product licensed so far under the abbreviated 351(k) pathway.

The industry has been waiting for some time for FDA’s policy position on nonproprietary naming of biological products, particularly for biosimilars and interchangeable biosimilars. With its position only partially decided in the draft policy, as described further below, the wait will go on while industry players continue advocating their positions to the Agency during the comment period.

So, what has FDA proposed?

In order to avoid inaccurate perceptions regarding the safety or effectiveness of biological products based on their licensure pathway – whether an original biologics application or an abbreviated biosimilar application – FDA has determined that the naming convention will apply to all biological products both prospectively and retrospectively. Per the draft guidance, all biological product nonproprietary names would consist of a core name and a designated four-letter suffix.  This convention will permit products with the same core name to be grouped together in electronic databases and systems, a benefit that would not be possible through use of a prefix. Continue Reading FDA’s New Four-Letter Guidance on Biosimilars

After finalizing three key guidance documents on biosimilars at the end of April (reported on our blog here), yesterday FDA released another “Question and Answer” guidance in draft form.  The draft guidance is called “Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.”  It includes the questions that were omitted from the finalized Q&A document and also several new questions and answers.  For example, two of the new questions address pediatric research requirements and how a sponsor should initiate discussion on pediatric study plans with FDA.  Another question deals with a technical issue regarding what dosage form of a proposed biosimilar would be considered the “same” dosage form as the reference product; and another offers details regarding how a non-U.S.-licensed product may be imported and used in a clinical study by a potential biosimilar applicant.

FDA is seeking stakeholder input on the Agency’s proposed responses to the revised and new questions, and it requests that interested parties submit their comments no later than July 13 to ensure that they are considered by the Agency as it begins work to finalize the document.  Notably, FDA has been criticized for the length of time it has taken to provide substantive guidance to potential sponsors of biosimilar applications, most recently in an open letter from a group of GOP Senators who called the FDA’s work so far to implement the BPCIA “opaque.”  The Senate letter also requested specific detailed information from the Agency on numerous issues.  We expect additional draft guidances on important biosimilar topics (such as the policy for nonproprietary naming) from FDA over the remaining months of 2015, and it will be interesting to see whether and how critics of the Agency’s BPCIA implementation efforts respond to any new actions taken by FDA.

On the heels of its approval of the first biosimilar product in March, FDA has just released final versions of three key biosimilar guidance documents under the Biologics Price Competition and Innovation Act (BPCIA). The newly finalized documents update draft guidance documents published in February 2012. Together, the three final guidance documents present FDA’s approach for determining biosimilarity and the critical scientific and quality issues that sponsors will need to address in their so-called “351(k) applications” (named after the new section added to the Public Health Service Act by the BPCIA).

Continue Reading FDA Finalizes Key Guidance Documents on Biosimilars