Off-Patent Biologicals and Biosimilars Tendering in Europe—A Proposal towards More Sustainable Practices

Abstract

Background: In Europe, off-patent biologicals and biosimilars are largely procured by means of tender procedures. The organization and design of tenders may play a key role in the evolving biosimilar market, and currently, it is not fully elucidated how tenders for off-patent biologicals and biosimilars are designed and if approaches are aligned with sustaining market competition and societal savings for healthcare systems over the long term. This study aims to (i) explore the design and implementation of tender procedures for off-patent biologicals and biosimilars in Europe, (ii) identify learnings for sustainable tender approaches from purchasers and suppliers, and (iii) formulate recommendations in support of competitive and sustainable tender practices in the off-patent biologicals market. Methods: A mixed methods design was applied. A quantitative web-survey was conducted with hospital pharmacists and purchasers (N = 60, of which 47 completed the survey in full), and qualitative expert-interviews with purchasers and suppliers (N = 28) were carried out. Results: The web survey results showed that the organization and design of tenders for off-patent biologicals and biosimilars, and the experience of hospital pharmacists and purchasers with this, considerably varies on several elements across European countries. From the qualitative interviews, signals emerged across the board that some of the current tender approaches might negatively affect market dynamics for off-patent biologicals and biosimilars. The focus on generating short-term savings and existence of originator favouring tender practices were identified as elements that may limit timely competition from and market opportunity for biosimilar suppliers. The need to optimize tender processes, considering a more long-term strategic and sustainable view, was expressed. In addition, challenges appear to exist with differentiating between products beyond price, showing the need and opportunity to guide stakeholders with the (appropriate) inclusion of award criteria beyond price. Due to the variety in tender organization in Europe, a ‘one size fits all’ tendering framework is not possible. However, on an overarching level, it was argued that tender procedures must aim to (i) ensure market plurality and (ii) include award criteria beyond price (warranted that criteria are objectively and transparently defined, scored and competitively rewarded). Depending on the market (maturity), additional actions may be needed. Conclusions: Findings suggest the need to adjust tender procedures for off-patent biologicals and biosimilars, considering a more long-term strategic and market sustainable view. Five main avenues for optimization were identified: (i) safeguarding a transparent, equal opportunity setting for all suppliers with an appropriate use of award criteria; (ii) fostering a timely opening of tender procedures, ensuring on-set competition; (iii) ensuring and stimulating adherence to laws on public procurement; (iv) securing an efficient process, improving plannability and ensuring timely product supply and (v) safeguarding long-term sustainable competition by stimulating market plurality.

Biosimilar Use and Switching in Belgium: Avenues for Integrated Policymaking

“…As a third point of consideration in the hospital setting, participants underlined the need for a revision of the hospital financing system, as the current set-up incentivizes hospitals to opt for products with high list prices. The price difference between the tendered price and list price is largely retained by the hospital, and accounts for an important portion (approximately 20% on average) of revenue of Belgian hospitals ( Belfius, 2020 ; Barbier et al, 2021 ). Products with a high list price allow for greatest margin between list price and tendered price and are as such of higher economic value for the hospital ( Dylst et al, 2014 ; Barbier et al, 2021 ).…”

“…The price difference between the tendered price and list price is largely retained by the hospital, and accounts for an important portion (approximately 20% on average) of revenue of Belgian hospitals ( Belfius, 2020 ; Barbier et al, 2021 ). Products with a high list price allow for greatest margin between list price and tendered price and are as such of higher economic value for the hospital ( Dylst et al, 2014 ; Barbier et al, 2021 ). Finally, also the availability of second-generation biologicals such as subcutaneous formulations for trastuzumab and rituximab were mentioned as reasons why the market opportunity for biosimilars is in some cases limited in hospitals (as currently only the intravenous formulations are available as biosimilar).…”

Awareness and Knowledge of Pharmacists toward Biosimilar Medicines: A Survey in Jordan

“…This could be explained that similarity between biosimilar medicine and its reference medicinal product does not mean they both have identical structure [ 1 – 4 ]. The FDA defines a biosimilar product as highly similar but not identical to an already licensed biologic product (also termed reference product or biooriginator) in terms of quality, safety, and efficacy [ 29 , 30 ]. Therefore, it is important to educate pharmacists accurately and promptly by shedding light on some of the confusion differences between biosimilars and their reference biologics [ 31 ].…”

When Will American Patients Start Benefitting From Biosimilars?

“…Besides the competitiveness of the product's price, other criteria may also be valuable to take into account, such as supply conditions or product administration device, when selecting 1 or multiple preferred products for the formulary. 21 The FDA has deployed large educational efforts to promote the use of biosimilars. It may well be that this kind of multidisciplinary action from within the health system may be key to making biosimilars also a success for patients in the United States.…”