New study on sustainability of the European off-patent biologics market

Since the early days of biosimilars development and commercialisation, Europe and the EU have been pioneers with regards to their regulatory approval and use. The European Medicines Agency (EMA) was the first to publish a biosimilar development pathway guidance in 2003 and the European Commission the first to grant a marketing authorisation for a biosimilar in 2006. European healthcare systems are now reaping the benefits, with a healthy competitive environment for off-patent biological treatments.

But are EU Member states taking advantage of the cost-savings associated with patent expiration of biological medicines to enhance patient access to these treatments?

A new study by the Pugatch Consilium, commissioned by EFPIA, shows that the answer to this question is “no”. Driven by an increasing demand for high quality healthcare and its associated costs, many European countries are focusing on maximising short-term savings rather than ensuring the long-term sustainability of the biological treatments market.

Building on a comprehensive policy environment analysis and on an Expert Opinion survey, the study provides a clear “Gold Standard” country roadmap to ensure long-term sustainability of off-patent biologic markets in terms of health system financing and efficiency, commercial, and patient access perspectives.

The Gold standard roadmap focuses on 5 pillars:

1. Rewarding innovation:
  • At its core a sustainable market for off-patent biologics should be built on incentivising biopharmaceutical R&D
  • Strong and clear incentives must be in place for continuous and sustained investment in innovative biologics as well as in off-patent biologics and biosimilars both from a R&D perspective as well as with regards to manufacturing
2. Healthcare financing:
  • Health care sustainability should be viewed from a holistic perspective recognising the long-term societal benefits and cost savings that sustainable competition and access to medicines provides European health systems
  • Pricing and reimbursement policies for all biologic products, including biosimilars, should be tailored to and reflect the unique characteristics of these medicines, including the substantial resources, risk and technical capacity required for developing and manufacturing a large molecule biologic medicine
3. Procurement practices:
  • Within a sustainable European market for off-patent biologics, procurement practices should:
a) be performed solely at a molecule level;
b) include the possibility of a wide variety of products from multiple suppliers (as opposed to a ‘winner takes all’ tender);
c) ensure an effective supply term that ranges between a minimum of 12 months and a maximum of 24 months; and
d) include an option for physicians to opt-out individual patients based on their medical needs at the physician’s discretion.

4. Physician autonomy and patient choice:
  • Physicians should have autonomy to prescribe what they consider to be the most appropriate medicine for their patients
  • The substitution of a biologic medicine with another biologic medicine should not happen automatically; it may only take place in cases where it is:
a) recommended by the physician; and
b) consented to by the patient.
  • Patients undergoing treatment should only be switched between biologic medicines if the following conditions are met:
a) The physician and the patient have both consented to the switch;
b) The patient is closely monitored following the switch.
  • Reliable and up-to-date information about the availability, cost-effectiveness and comparative assessment of off-patent biologics and biosimilars should be fully transparent and accessible to physicians
5. Pharmacovigilance and traceability frameworks:
  • A robust pharmacovigilance system for reporting and analysis of ADRs should be in place and healthcare professionals should be aware of the importance of reporting ADRs by brand name and batch number
  • All biologic products should be prescribed by the product’s brand name in order to avoid unintended switching of treatments and ensure effective traceability of ADRs
The sixth component of the Gold Standard details the policies and measures the countries should refrain from in order to secure the sustainability of the off-patent biologics market:

6. Policies with a potential to undermine sustainability of the market:
  • Treating off-patent biologics as ‘bio-generics’ by adopting policies or measures aimed at generating savings or inducing uptake that may be in place for generic medicines that do not require an extensive R&D phase and that are significantly less complex to produce compared to biosimilars
  • Adopting extreme discriminatory measures and/or preferential treatment (including within the pricing and reimbursement, procurement and clinical practice aspects) that impede competition and may limit physician autonomy and patient choice
  • Placing physicians and patients under unwarranted restrictions or limitations with regards to their freedom to choose the most suitable treatment for their needs
  • Using policies such as INN prescribing and/or pharmacy-level substitution that greatly complicate product traceability in cases of adverse drug reactions
In the end, being a pioneer that others look-up to as global model brings responsibilities. For patients, caregivers, hospitals, manufacturers and payers alike, it is important that governments enter a new mature phase in biosimilar policy making, enabling a sustainable market environment, in which high quality of care, safety, affordability and accessibility to treatment is guaranteed. The standards researched and developed by this new study, may help to guide them on this path.

Nathalie Moll

Nathalie Moll joined the European Federation of Pharmaceutical Industries and Associations (EFPIA) as Director...
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