DRugwatch BlogRSS 2.0

DRugwatch Blog > January 2013 > Biosimilars: States Forge Ahead While Awaiting FDA Action

Biosimilars: States Forge Ahead While Awaiting FDA Action

Contributor: Joseph Martinez

Last year the FDA finally issued draft guidelines for biosimilar approval in the US. In light of the coming 2016 ‘patent cliff’ for many branded biologic therapies that was previously discussed in a post by Gary Sing, progress on these guidelines is happening just in time. In the past week there has been a lot of talk about state legislatures moving ahead with regulations regarding substitutions of branded agents with biosimilars. However, the key rate-limiting step still rests with the FDA. How attainable the interchangeable designation is will have a dramatic impact on the profitability and rate of market erosion of biosimilars.

Illinois, Virginia, Pennsylvania, Texas, North Dakota, Indiana and most recently Massachusetts are all proposing or moving to vote on amendments to their generic-equivalent laws to include guidance on biosimilars. In Virginia last week, the Committee on Health, Welfare and Institutions in the House of Delegates passed such a bill 6-2. These amendments intend to establish that pharmacies can only substitute if the FDA licenses a biosimilar as interchangeable and then only if the physician does not specify “brand medically necessary.”

However, while states are pushing to establish guidelines for that hypothetical scenario, the crux of the issue is whether interchangeability would even be an FDA option. Canada has dubbed biosimilars not interchangeable, instead filing them as subsequent-entry biologics (SEB).  While the European Medicines Agency has approved several biosimilars, the law makes no mention of interchangeability. That issue instead has been left to individual countries to decide, on which fifteen nations have prohibited automatic substitution.

So far the FDA has established a theoretical opening for approval of an interchangeable biosimilar without specific guidance on the requirements. Since biologics are defined more by their unique production processes rather than a well-defined chemical structure, potential differences in immunogenicity, half-life and clearance time stemming from the manufacturing process would need to be tested in costly switching studies. In all likelihood, interchangeability requirements would vary by class: recombinant proteins versus monoclonal antibodies, for example. On top of these complications, competing demands from all the interested parties in addition to the typically slow process of FDA guideline issuance will likely even further delay matters. In light of this, the agency itself doesn’t expect an interchangeability designation to be achievable for the first wave of biosimilars approved.

For all the recent hype about automatic substitution of biosimilars at the state level, the key market shaper is still the FDA. In its forecasts, the DRG Biosimilar Advisory Service (BAS) does not currently assume automatic substitution will occur. If biosimilars are unable to prove interchangeability with the branded product, the rate at which physicians switch patients would likely be lowered initially due to the lack of usage history. BAS forecasts that biosimilar erosion will be lower than small-molecule generic erosion rates, but will depend on the biologic type: while insulin therapies will erode very slowly, oncology biologics will see relatively faster erosion. In short, a lack of automatic substitution would likely initially limit biosimilar profits and help to ameliorate sales erosion of blockbuster biologics.

Joseph Martinez is an Associate with the DRG Consulting group.
 

Sources:
Regulatory Focus: Biosimilar Interchangeability Problems Pose Complex Challenge for Regulators
FDA Law Blog: Biosimilar Substitution: Battles are Brewing at the State Level
BioTrends Biosimilar Advisory Service: Biosimilars 2007-2017: Shifting Payer and Physician Opinion Increases the Hurdles to Uptake

Posted on: 1/24/2013 8:53:38 PM | with 0 comments


Tags: Biosimilars, Joseph Martinez,

Trackback URL: http://decisionresources.com/trackback/df6bf636-2389-4a68-a09e-79ec0e88acf4/Biosimilars--States-Forge-Ahead-While-Awaiting-FDA-Action.aspx?culture=en-us

Comments
Blog post currently doesn't have any comments.
Leave comment Subscribe



What is the abbreviation for Accountable Care Organization?

 

rss twitter linkedin

 

DRugwatch Blog

Quick insight on intriguing drug market developments from Decision Resources’ analysts.

Recent posts

Post title:
2015 ESC Congress in London – Overview of Upcoming Hot Line Sessions
Post date:
7/2/2015 11:57:46 PM
Post Summary:
Conor WalshContributor: Conor Walsh M.Sc., Ph.D.
Topics: Conference Commentary, Cardiovascular

This year’s ESC congress will take place in the Excel Exhibition Centre in London, United Kingdom. The spotlight this year is “environment and the heart,” highlighting the many different kinds of interactions between the environment and cardiovascular diseases.

Post title:
FDA Approval for The Medicines Company’s Intravenous Antiplatelet Kengreal
Post date:
6/23/2015 1:22:54 PM
Post Summary:
Conor WalshContributors: Conor Walsh, M.Sc., Ph.D.
Topics: Cardiovascular

On June 22nd, 2015 the U.S. FDA approved Kengreal (cangrelor), the Medicines Company’s intravenous antiplatelet drug for use “as an adjunct to percutaneous coronary intervention (PCI) for reducing the risk of periprocedural myocardial infarction, repeat coronary revascularization, and stent thrombosis in patients in who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor.”

Post title:
Hematological Malignancies: Are Immune Checkpoint Inhibitors Checking-in?
Post date:
6/17/2015 9:32:42 AM
Post Summary:
Contributor: Dana Gheorghe, Ph.D
Topics
: Conference Commentary, Oncology


Recent years have seen an added emphasis on the relationship between cancer and the activity of the immune system. Novel agents that aim to harness the immune system have already been approved in the U.S. for solid tumors (Bristol-Myers Squibb/Ono Pharmaceutical’s Opdivo [nivolumab] for NSCLC and malignant melanoma, and Merck & Co.’s Keytruda [pembrolizumab] for malignant melanoma), and are in development for a plethora of other oncology indications. Most of the development has been targeted towards solid tumors, but the potential of immune checkpoint inhibitors in hematological malignancies is becoming increasingly evident.

Post title:
Cardiovascular Outcomes Trials Answer Long-Asked Questions – But New Questions Arise
Post date:
6/12/2015 10:26:05 AM
Post Summary:
Contributor: Eamonn O'Connor, Ph.D.

The recent American Diabetes Association’s 75th Scientific Sessions in Boston saw the release of data from the ELIXA cardiovascular outcomes trial (CVOT) for lixisenatide (Sanofi/Zealand Pharma’s Lyxumia), the first such trial completed for the GLP-1 receptor agonist drug class. However, it was the publication of the data from the CVOT for sitagliptin (Merck’s Januvia/Ono’s Glactiv), known as TECOS1, that was most eagerly anticipated; this is because the previous CVOTs for saxagliptin (AstraZeneca’s Onglyza) and alogliptin (Takeda/Furiex’s Nesina/Vipidia) had raised significant concerns about a potential risk for increased rates of hospitalization due to heart failure. The results from TECOS therefore, were viewed as pivotal as to whether this risk was a feature specific to the DPP-IV inhibitor drug class.

Post title:
Malignant Melanoma: Evolving Standards of Care
Post date:
6/5/2015 2:52:20 PM
Post Summary:
Contributor: Natalia Reoutova, M.Sc.
Topics: Conference Commentary, Oncology

The past five years have seen unprecedented progress in the treatment of malignant melanoma, which translated into approval of highly efficacious immunotherapies, targeted small-molecule therapies, and several combination regimens.

Decision Resources Group brands include: