The Changing Landscape and Evolution of Biosimilars

If you search for “Biosimilars” in Google, you will get over 500,000 results – a massive source of information that includes scientific articles, guidelines, positions, product information, stakeholder perspectives and much more on the topic.

Biosimilars have already been the subject of  hot debate for more than a decade, and they still are.  This is very well-illustrated by looking at Google trends, which shows a steady increase of interest in this keyword between 2005 and 2015.



However, the specific topics around biosimilars being discussed have changed dramatically over time. Until 2006, there was no practical experience with biosimilars and most the discussions taking place were still very theoretical. Ten years later, the topic of biosimilars has evolved into something much more tangible; in Europe, we currently already have 20 biosimilars on the market (source: EMA homepage).

The views and opinions of stakeholders involved in these discussions have also changed during this period. For example, the EMA transformed its initial risk-based approach to biosimilars into a much more science-driven approach (source: DIA Biosimilar meeting 2015).  Industry associations like EBE, EBG and EuropaBio became very active in the field and published or presented their views on topics like biosimilar development, substitution of biologics and biosimilar labeling.  Furthermore, we saw healthcare professionals and patients start prescribing and using biosimilars and then become active on the topic. There have been public debates such as in workshops organised by the European Commission (DG Grow) to discuss “access to and uptake of biosimilar medicinal products.”

Initially, a large group of people could not imagine that extrapolation of data from one indication to another would be allowed; now, we are having discussions on whether or not clinical studies are still required to prove biosimilarity.  Also, where the initial focus was on how to prove similarity, discussions are now taking place on how to prove that products are interchangeable, and if additional data to demonstrate this are needed at all. An increasing number of member states are taking a clear position on this topic of interchangeability.

As you can see from the two examples above, the topic of biosimilars is very dynamic and there are still many unanswered questions. Many key stakeholders are currently still making up their minds and expressing their views on topics such as the need for clinical trials,  the level of difference one can accept between biosimilars and originators, post-authorization requirements, how far extrapolation can go, how to maximize product traceability, the risks related to immunogenicity when switching patients, and how to deal with biologics pharmacovigilance when patients are being switched from the originator to the biosimilar and vice versa.

All of these constantly evolving topics always make it interesting to follow the discussions taking place at the DIA biosimilar meeting. Stakeholders represented at the DIA Biosimilar meeting have changed, especially over the last few years, and the voice and representation of physicians, pharmacists and patients has become stronger.

Public consultations and exchanging experiences and knowledge between relevant stakeholders have proven to be a cornerstone of the well-established regulatory framework for biosimilars in Europe – a framework that has been leading the way globally. Therefore, keeping these multi-stakeholder discussions going are of upmost importance. I am pleased to see that DIA continues to provide a forum for these types of multi-stakeholder discussions.


Marloes van Bruggen, Regional Regulatory Policy Lead – EEMEA, F.Hoffmann-La Roche Ltd.



  • EBG = European Biosimilars Group
  • EBE = European Biopharmaceutical Enterprises


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Full Course of Direct Acting HepC Antiviral Now Available to All Australians

The full twelve-week course of direct acting hepatitis C antiviral oral medicines are now available to all Australians for the subsidized price of a little over A$100.00, or even less for concession card holders. This will allow all patients with this disorder, irrespective of socioeconomic status, genotype of the virus or the presence of cirrhosis to be cured and thereby reduce the risk of cirrhosis and liver cancer.  The goal is to eradicate this disease in Australia.

by Dr. Richard O. Day, DIA Fellow; DIA Global Forum Regional Editor: Australia/New Zealand; Professor of Clinical Pharmacology, St. Vincent’s Hospital, Australia

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Australian Update: Changes to TGA and PBS

TGA is undergoing changes in response to a ‘Functional and Efficiency Review’ of the Department of Health – there is now a ‘Regulatory Service Group’ that includes TGA, the Office of Gene Technology Regulator and the Office of Chemical Safety. There is also a new Regulatory Performance Framework with KPIs that the TGA’s performance will be measured against. The first report is due in the second half of 2016.

How to overcome resistance to biosimilars that are now being listed on the Pharmaceutical Benefits Scheme in order to reap the financial benefits for the taxpayer is an issue for Government. This topic will be addressed as part of a PBS Access and Sustainability Package just announced, with $20 million funding for 2015-18.

by Dr. Richard O. Day, DIA Fellow; DIA Global Forum Regional Editor: Australia/New Zealand; Professor of Clinical Pharmacology, St. Vincent’s Hospital, Australia

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Towards a More Intramural Approach to Biomarker Development

A recent article by Shashi Amur and FDA colleagues on the future of biomarker development (Biomarker Qualification: Toward a Multiple Stakeholder Framework for Biomarker Development, Regulatory Acceptance, and Utilization provides a solid foundation for ongoing development and review process for biomarker qualification. FDA should be applauded for their progress in agency collaboration with the Critical Path Institute (in biomarker consortia development), the recent total kidney volume and plasma fibrinogen prognostic marker approvals, and sponsorship of interactive sessions such as the recent CERSI meeting at University of Maryland, as well as their EMA partnership to facilitate collaborative review of drug development tool qualification.

We would encourage additional measures to hasten biomarker development, including:

  • Maximizing Expert Resources: FDA needs adequate resources to provide advice and oversee review and decision-making. One solution is to partner with an external entity (an Intramural Biomarker Consortium-IBC) to develop early advice and serve as an expert sounding board for nascent biomarker efforts.  The IBC could be a required or voluntary resource in the review process, especially for initial data package reviews. This approach would allow FDA staff to focus on their primary role of product review and regulatory oversight.
  • Refined Evidentiary Considerations: The product development and research community should collaborate to support FDA in developing a framework for the proper level of evidentiary substantiation required for qualification and the criteria used to evaluate them – such that FDA can issue guidance -standards which do not exist today.  The IBC could be charged with overseeing relevant workshops and the drafting of initial guidance documents (consistent with FDA’s Good Guidance Practice recommendations and provided FDA is actively participating and has final approval).
  • Qualification Plan: FDA should clarify the components of individual qualification plans and judge submitted data packages against them.  Decisions not to qualify a proposed biomarker for a particular context should be accompanied by an explanation of the evidentiary gaps between the agreed plan and the submitted qualification package. IBC could work with biomarker developers to build these plans and perform initial data package reviews.
  • Enhance Learning:  Give FDA the authority to share information about biomarker qualification programs that are being advanced through collaborative efforts. Much can be learned by reviewing successes and failures across ongoing biomarker programs, and would inform the broader research community to enable refined evidentiary standards.
  • Timeliness: FDA must clarify and communicate timelines for the qualification process in order to foster predictability and encourage participation.  Such resources could be provided via PDUFA VI.

FDA can further solidify its place squarely in the center of the innovation ecosystem by fostering collaborative alliances with all stakeholders, enhancing qualification planning, sharing developmental endeavors, and clarifying standards.

Peter J. Pitts
President, Center for Medicines in the Public Interest
Former FDA Associate Commissioner

Timothy R. Franson, M.D.
Chief Medical Officer – YourEncore
Immediate Past President- US Pharmacopeial Convention

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Whither Off-Label?

By Peter J. Pitts

The debate over off-label communications doesn’t begin or end with the Caronia or Amarin decisions. It’s a continuing dialogue between manufacturers and the FDA, between doctors and patients, between doctors and academics, between lawyers and judges, and between advocates on all sides.

And the red thread that ties these conversations together is responsible off-label communications. Not sales strategies. Not DTC tactics. Not managed market negotiations – the responsible sharing of truthful and accurate information. Continue reading

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The FDA’s Quality Revolution

By Peter J. Pitts

Let it be said that the spark that ignited the flame was when FDA leadership asked, “Do we know enough about the quality of drugs that are sold in the United States.”

So said, CDER Director Dr. Janet Woodcock during yesterday’s webinar, “Understanding CDER’s “Super” Office Of Pharmaceutical Quality and Its Effect on You.”  Dr. Woodcock was joined by Dr. Lawrence Yu. I was honored to moderate the FDA News-sponsored session.

(Janet is the acting director of the OPQ and Lawrence is the acting deputy.)

Let’s put the new OPQ into some historical context. Continue reading

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The Globetrotting Regulator

By Peter J. Pitts

I am putting in a lot of miles on behalf of international regulatory fraternity.

Over the last few months I’ve visited Egypt, Indonesia, Vietnam, Taiwan, Mexico, and Brazil, where I’ve had privilege to meet with regulatory and healthcare officials. (And boy, are my arms tired.)  Many things were discussed and shared, but the red thread was the urgency of quality.

I’ve learned many things and met many remarkable people. Perhaps the most important thing I’ve come to appreciate is that we need to stop talking about regulatory “harmonization” and focus our time and attention on regulatory “convergence.” Just as every nation has it’s own unique culture and cuisine, so too must it design it’s own regulatory philosophy and structure. It’s not about replicating the USFDA or the EMA – it’s about converging towards best practices — and beware the danger of regulatory imperialism. Continue reading

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Message from DIA 2015 51st Annual Meeting Program Co-Chair Dr. Michael Rosenblatt

Mobilizing medical insight, discovery and invention to help patients is a team effort. Patients and their families expect that we will work collaboratively and use our collective skills to improve health – as efficiently and quickly as possible. No doubt, collaboration is a skill and a challenge. Honing that skill and exploring the challenge requires conversation and expression. The DIA 2015 51st Annual Meeting gathering in Washington, DC, is the perfect place to pursue our shared mission to improve health and well-being, and to learn how to be great partners in drug development from each other. Continue reading

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Disruptive Innovation in Health Care

Disruptive innovation, creating new markets and displacing the old, is currently in the midst of a “big bang.” Technology is serving as the catalyst and helping to develop new breakthroughs, which in turn are spurring on further developments.  Hardware, wearable gadgets, and new medical technologies are raising the level of innovation in health care product development.  These rapid advances are creating opportunities to advance research and connect patients to their care. Continue reading

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In Case You Missed It: April Global Forum Looks at Industry Trends Across the Globe

Have you read the April issue of Global Forum yet? Featuring a new look, and in-depth content from an expanded editorial board, this issue is available open access (no log in required) at

The April issue takes a deep-dive look at the 10 industry trends for 2015 identified in our recent “What Lies Ahead” report (view pdf). In addition to a Special Section with feature articles on three of the top trends, we also asked experts from around the globe to comment on how they see these trends shaping up in their area of the world.

Dr. Silke Vogel, Associate Dean at Duke-National University of Singapore, providing insight into which of the identified trends resonated for ASEAN community.

Dr. Richard Day surveyed his colleagues and peers in Australia and New Zealand for their opinions on the trends as they impact the “down under.”

Dr. Ling Su and Fuyu Song offered their take on What Lies Ahead in China.

For the European Perspective, John Lisman weighed in with the themes he sees trending in Europe.

We also look at areas where the industry is still growing. Professor Ranjit Roy Chaudhury lends his extensive expertise in a commentary on the trends in India, while Vincent Ahonkhai offers perspective on industry trends in Middle East/Africa.

How do you see these trends impacting work in your corner of the world? Let us know in the comments.

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