For our final spotlight blog, we are delighted to feature our Biotherapeutics Working Group, which will have their last get-together of the year today. This working group originally focused on biosimilars and related regulatory challenges, but it eventually expanded to include all biotherapeutics, including innovative therapeutics, for example antibodies, and how they are regulated.
Biologic medicines (including biosimilar medicines) come from living organisms, such as living cells, that have been modified using biotechnology. The modification allows these living organisms or cells to produce the active substance of the biological medicine, for example proteins or hormones like insulin or growth hormone. These active substances are usually larger and more complex than those of non-biological medicines, often called small molecule medicines. While identical generic versions of small molecules can be chemically synthesized, due to their complexity it is not possible to create identical versions of reference biologic medicines. However, it is possible to develop biologic medicines that are so similar to an existing and already approved biologic medicine that there is no difference in respect to their efficacy and safety. Such medicines are called biosimilars.
Europe is the trailblazer for enabling pathways for biosimilars, and our Biotherapeutics Working Group provides industry considerations into the development of regulatory approaches. These are often very technical discussions, like this year’s workshop by the European Medicines Agency (EMA) on the reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development, where our experts provided input.
The working group also addresses other regulatory challenges for biotherapeutics, for example around antibodies. The group is contributing to a reflection paper on the joint industry position on product specific guidelines for monoclonal antibodies, to ensure that the regulation does not negatively impact innovation.
In 2019, the group is launching a work stream to draft a reflection paper on the sharing of EMA assessment reports with regulators across the world regions, in support of promoting reliance and expedited registration pathways across regions based on EMA approvals. The activity will be developed in close discussion with other interested associations, like the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), potentially even as a joint effort. This is a continuation of our group’s efforts to help other regions benefit from Europe’s experience, which also saw EBE host a session on 4 June at this year’s BIO convention “Going Global with Biosimilars: How are Biosimilars Regulated Around the World Today”.
Europe has truly taken the lead on biotherapeutics – and our working group is helping to forge the path ahead.
The Biotherapeutics working group is one of five EBE working groups, including Personalised Medicine, Advanced Therapies, Innovation and Funding Models, and Biomanufacturing – with this last blog, that’s a wrap on our spotlight series!