• Biosimilar Automatic Substitution In The EU5: Current State & Future Outlook
    Biosimilar Automatic Substitution In The EU5: Current State & Future Outlook

    At present, automatic substitution of biosimilars at a pharmacy level is not practiced in the EU5. Recent and future changes in the EU5 market access environment and regulatory landscape may favor automatic substitution, but implications on the biosimilar market are yet to be determined.

  • FDA’s Woodcock: Biosimilar Development Promotes Future Of Better Biologics
    FDA’s Woodcock: Biosimilar Development Promotes Future Of Better Biologics

    While some regulators may express skepticism that we’ll see major changes to the clinical component of the biosimilar development pathway, Woodcock’s DIA keynote exemplified what I found to be a strikingly different attitude about the future possibilities for biosimilar development.

  • A Delicate Balance: Patent Exclusivity, Innovation, And Competition
    A Delicate Balance: Patent Exclusivity, Innovation, And Competition

    Overall, arguments calling into question the value of biologics competition tie into what I think is an even more important question worth asking in this country: What global responsibility does the U.S., as the largest pharmaceutical market, have in terms of promoting greater access to medicines?

  • Do The Arguments For Pharmaceutical Price Increases Make Sense?
    Do The Arguments For Pharmaceutical Price Increases Make Sense?

    This article will share recent analysis of price increases within the healthcare sector in an effort to understand the growth of healthcare expenditures and pharmaceutical prices over time.

  • Breaking Down Amgen’s Win In The Biosimilar Enbrel Patent Fight
    Breaking Down Amgen’s Win In The Biosimilar Enbrel Patent Fight

    Following a trial in the District Court of New Jersey, Sandoz has been barred from marketing a biosimilar version of Amgen’s Enbrel product. Due to the scarcity of biologics patent case rulings, this case provides an interesting precedent for how future decisions may treat biologics patent issues.

  • FDA’s Top 5 Drug GMP Inspection Citations In FY2018 — With FDA Analysis
    FDA’s Top 5 Drug GMP Inspection Citations In FY2018 — With FDA Analysis

    This is the second part of a two-part article counting down the FDA’s top 10 most-common drug GMP inspection citations for the agency’s 2018 fiscal year (FY2018).

  • Stakeholders To Gather In D.C. To Discuss U.S. Biosimilar Market’s Future
    Stakeholders To Gather In D.C. To Discuss U.S. Biosimilar Market’s Future

    Prior to the DIA Biosimilars Conference, I wanted to catch up with speaker Julie Reed of Pfizer to see what she’s most excited about imparting to attendees and what she hopes to learn from the upcoming conference.

  • Canadian Patients Speak Out In Favor Of British Columbia Biosimilar Transition
    Canadian Patients Speak Out In Favor Of British Columbia Biosimilar Transition

    I reached out to learn the inflammatory arthritis patient community’s thoughts on BC's large-scale transition to biosimilars. I also wanted to know which best practices the government employed behind-the-scenes to ensure the policy would be a success.

  • What Celgene Corp. v. Peter Means For Biosimilar Developers
    What Celgene Corp. v. Peter Means For Biosimilar Developers

    A recent decision by the U.S. Court of Appeals for the Federal Circuit has indicated that pharmaceutical makers with patent protection are unlikely to receive any compensation from the government for the loss of their patents during inter partes review (IPR) decisions by the Patent Trial and Appeal Board (PTAB).

  • How One Rheumatology Practice Bolstered Uptake Of Biosimilar Infliximab
    How One Rheumatology Practice Bolstered Uptake Of Biosimilar Infliximab

    In this article, Dr. Edgerton walks me through AHG’s considerations and efforts in gaining payer buy-in on this value-based pathway, as well as how this initiative has given rise to a new, rheumatology-centric group purchasing organization (GPO) known as the Articularis Rheumatology Network (ARN) GPO.

  • Fixing The Follow-On Insulin Regulatory Approval “Dead Zone”
    Fixing The Follow-On Insulin Regulatory Approval “Dead Zone”

    With all the attention on the costs of pharmaceutical products, there is an upcoming regulatory “dead zone” that will potentially delay market entry of certain insulin products, adversely impacting insulin prices for consumers and payors. A recent Senate bill has been proposed to address this regulatory anomaly. Industry players should monitor this bill and other efforts to address the insulin dead zone, given how critical this product is to so many people.

  • Why This Biosimilar Initiative In Rheumatology Is One To Watch
    Why This Biosimilar Initiative In Rheumatology Is One To Watch

    In the first of what will be two articles, I’ll share how one large rheumatology practice, AHG, established a value-based pathway that increased its providers' reliance on infliximab biosimilars.   

  • Is It Time To Throw In The Towel On Biosimilars In The U.S.?
    Is It Time To Throw In The Towel On Biosimilars In The U.S.?

    Rob Wright takes issue with Peter Bach, M.D., and Mark Trusheim’s recommendation that the U.S. would be better served by abandoning continued biosimilar drug development.

  • A Bite-Sized Analysis Of The PDPRA For Biosimilar Makers
    A Bite-Sized Analysis Of The PDPRA For Biosimilar Makers

    In light of all the noise surrounding this Act, I reached out to reimbursement policy guru and Biosimilar Development editorial board member extraordinaire, Molly Burich. Here, she shares her initial thoughts on how several proposed changes to alter reimbursement under Medicare Part B and D could play out in the biosimilar space should the bill be made law.  

  • 2 Bills, 1 Goal: Lower Drug Prices Through Biosimilars
    2 Bills, 1 Goal: Lower Drug Prices Through Biosimilars

    Just prior to an election season, it is not surprising to see a few bills emerge as potential silver bullets to solve pressing policy issues. One issue that has consumed the public for several years is drug prices. This article examines two Congressional bills aimed at increasing biosimilar utilization in an effort to lower drug costs.

  • A Second Reformation: Returning Biosimilar Regulations To Scientific Roots
    A Second Reformation: Returning Biosimilar Regulations To Scientific Roots

    In light of BioApproval's Chris Webster’s recent publication and future presentation at the upcoming DIA Biosimilars conference, I spoke with him to learn more about the "Confirmation of Sufficient Likeness" approach and the scientific evidence that has informed this proposed biosimilar regulatory paradigm shift away from Totality of Evidence.

  • Breast Cancer Patient Organization Sets Sights On Biosimilars
    Breast Cancer Patient Organization Sets Sights On Biosimilars

    During our discussion, I learned more about this patient organization and its biosimilar education goals, as well as what type of information could be particularly helpful for the breast cancer patient community at this point in time.

  • What Can Cell & Gene Efforts Teach Biosimilar Makers?
    What Can Cell & Gene Efforts Teach Biosimilar Makers?

    Not only are the issues impacting cell and gene therapies relatable on the biosimilar side, I’m hoping this particular strategy can inspire creative thinking as scrutiny into the buy-and-bill landscape continues to intensify.

  • Cutting Through The Noise: The Bright Side Of Biosimilar Progress
    Cutting Through The Noise: The Bright Side Of Biosimilar Progress

    Because negative news and opinions seem to create greater waves, I thought I would take stock of the positive news that may not have come over your desks or (more realistically) cellphones in the past few weeks. While it’s easy to get bogged down by negative speculation, there’s progress being made and companies and experts fighting daily to keep this industry moving forward, even if it feels glacial.

  • FDA, USP Debate Standards: How Could This Impact Biosimilars?
    FDA, USP Debate Standards: How Could This Impact Biosimilars?

    Even though the FDA has argued quite passionately against the need for biologics standards, there are several reasons why I hesitate to embrace their arguments that having these standards in place (and requiring they be met) could be harmful to biosimilars.

  • Employer Roundtable Highlights Biosimilar Knowledge Gap
    Employer Roundtable Highlights Biosimilar Knowledge Gap

    Though this event encompassed a small cross-section of employers, the discussions and questions asked about biosimilars revealed the topics that need to be considered, reiterated, and regularly reinforced.

  • The Debate On Standards In Biologics Development Heats Up
    The Debate On Standards In Biologics Development Heats Up

    Though it’s only natural to expect animated scientific discussion between the FDA and USP which have long been partners-in-science, I found myself caught off-guard by just how firmly the FDA has been putting its foot down and making its thoughts known on the role certain standards — in particular, USP monographs — should (or should not play) in biologics development.

  • The Progress And Pitfalls Of Global Biosimilar Development
    The Progress And Pitfalls Of Global Biosimilar Development

    While we’ve certainly seen progress on the march towards true global development, there’s still a way to go. There were several points I learned recently that stood out about which regulatory inconsistencies still exist between developed nations, as well as how certain aspects of regulatory science can be improved upon in the future.

  • How Can Biosimilars Make Headway In The U.S. Market?
    How Can Biosimilars Make Headway In The U.S. Market?

    ISPOR, the professional society for health economics and outcomes research (HEOR), recently held its annual conference, which brought together nearly 4,000 researchers, regulators, payers, drug developers, providers, and other stakeholders from across the healthcare continuum. During one panel session, experts in biosimilar regulatory, legal, and reimbursement discussed the crucial elements needed to foster a robust and sustainable U.S. biosimilars marketplace over the long term.

  • USP Highlights Biosimilar Analytical Development Challenges, Possibilities
    USP Highlights Biosimilar Analytical Development Challenges, Possibilities

    During our conversation about the FDA’s most recent comparability guidance, I picked one USP expert's brain about the challenges of establishing a biosimilar analytical development program, as well as why certain types of data may be more difficult to come by than others. These challenges are responsible for further complicating the question about which types of data are still necessary, and why.  

  • FDA’s “Show Me The Data” A Recipe For Tailored Biosimilar Development?
    FDA’s “Show Me The Data” A Recipe For Tailored Biosimilar Development?

    In this first of what will be a two-part article, USP's Fouad Atouf highlights the challenges presented by the FDA’s newest guidance while remaining optimistic that the large amount of data recommended today will open doors to more efficient development in the (hopefully) near future.

  • Why We Should Celebrate The FDA’s Biosimilar Comparative Analytics Guidance
    Why We Should Celebrate The FDA’s Biosimilar Comparative Analytics Guidance

    Despite the importance of the process the FDA is outlining in the guidance, I’ve surprisingly heard little chatter — positive or negative — about what the agency is now outlining and what this may mean for biosimilars and the biosimilar regulatory paradigm moving forward. Here are a couple of the biggest takeaways to note.

  • Physicians Speak Out About Biosimilar Value
    Physicians Speak Out About Biosimilar Value

    I particularly enjoyed a conversation amongst a panel of physicians at a recent conference, several of whom elaborated upon the value increased use of biosimilars can bring to the table — both for patients and physicians. And though savings and access are main goals, physicians also see another critical benefit of greater biosimilar use.

  • Will Biosimilars Solve The Insulin Cost-Conundrum In The U.S.?
    Will Biosimilars Solve The Insulin Cost-Conundrum In The U.S.?

    The debate on drug pricing is raising questions about why U.S. patients pay some of the highest fees in the world to access prescription medicines. Politicians are putting manufacturers of insulins under particular scrutiny.

  • Medicare Negotiation And Competitive Licensing Act: An Ambitious Challenge To Biologic Patents
    Medicare Negotiation And Competitive Licensing Act: An Ambitious Challenge To Biologic Patents

    In recent years there has been growing, bipartisan support to address the perceived high cost of biologic drugs. Indeed, recent estimates are that biologic drugs account for approximately 40 percent of all U.S. pharmaceutical sales and 70 percent of drug spending growth between 2010 and 2015.

More From Biosimilar Regulatory solution center

ABOUT BIOSIMILAR REGULATIONS

The first biosimilar was approved for the European market in 2006. While the regulatory pathway for biosimilars in the U.S. was created as part of the Affordable Care Act in March 2010, the first biosimilar was only recently approved for the U.S. market in March 2015.

Biosimilars are essentially generic versions of large molecule biologics. However, the fact they are not exact copies of the reference product makes establishing regulations for their approval and release to market a more complicated process. The WHO, along with many other parties in the pharmaceutical industry, has argued that regulations governing the development and approval of small molecule generics are not appropriate for more complex biological medicines. As such, the WHO set out to establish regulations articulating the efficacy, safety, and quality standards biosimilars must meet and maintain to make it to market. These regulations specify that a biosimilar must prove its biosimilarity to a reference product through head-to-head comparisons. The biosimilar company must also submit non-clinical and clinical studies data and a pharmacovigilance plan to the appropriate regulatory body. Those navigating the landscape of current biosimilars regulations face the challenge of demonstrating a biosimilar’s safety, purity, efficacy, and potency.

The current U.S. Food and Drug Association (FDA) and European Medicines Agency (EMA) regulations for biosimilars require these biologic copies to undergo extensive analytical chemistry, manufacturing, and control (CMC) and clinical processes to prove similarity to the reference product. However, in comparison to the originator biologic, a biosimilar could see an accelerated approval process, as it might need less data to meet the established regulations. The EMA was the first regulatory authority to establish marketing regulations for biosimilars in 2005. Other countries including Australia, Canada, Japan, Korea, and South Africa have since turned to the EMA’s regulations, as well as the WHO’s regulations, as a model for crafting their own regulations. In 2012, the FDA released three draft guidances to assist biosimilar developers in demonstrating their product’s biosimilarity. To comply with existing U.S. regulations, manufacturers are expected to include structural analysis, functional assays, and data from animal and human clinical trials in their applications. As biosimilar production spreads globally, regulations have continued to shift and evolve. Currently, each governing body has differing definitions/terminology for biosimilars, and as such, has established varying regulations dictating what studies and data are needed to be approved for the market.