The US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) announced on 3 February 2020 that they would enhance their collaboration when it comes to anti-competitive behaviour in the biologicals’ marketplace.
The two agencies released a joint statement describing ‘key steps’ they will take ‘to address false or misleading promotion about biosimilars within their respective authorities and deter anti-competitive behaviour in this space’.
Biosimilars uptake in the US has been slow to say the least. In fact, biosimilars currently make up only 2.3% of the US biologicals marketplace. Currently, 90% of global biosimilars sales take place in Europe, despite 60% of overall biologicals sales occurring in the US [1].
One reason for this lack of uptake for biosimilars has been highlighted as being deliberate misinformation, which has sown confusion and doubt with patients and physicians [1]. In fact, FDA has been called upon to issue guidance ‘clarifying appropriate sponsor communications about the nature and properties of biosimilars’ [2].
As part of efforts to increase biosimilar competition, FDA points to its Biosimilars Action Plan (BAP), which was issued in July 2018 [3]. While, with respect to combating anti-competitive behaviour, the agency points to guidance issued in September 2019 related to certain types of citizen petitions intended to delay FDA action on a generic or other abbreviated applications [4].
The FTC, on the other hand, states that, according to its analysis ‘competition generated by biosimilars could generate significant consumer benefit’.
Both agencies say that they support competitive markets for biologicals and add that they ‘have serious concerns about false or misleading statements and their negative impacts on public health and competition’. They therefore intend to focus on false or misleading communications about biosimilars within their authorities. While FDA also intends to ‘undertake efforts to educate healthcare professionals and patients about biosimilars and explain why people should have confidence in the safety and effectiveness of these FDA-approved products just as they would the reference products’.
The agencies conclude that they ‘believe these actions will facilitate a more competitive marketplace’.
Related article
Obstacles to biosimilars uptake in the US
References
1. GaBI Online - Generics and Biosimilars Initiative. The sluggish US biosimilars market [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Mar 20]. Available from: www.gabionline.net/Reports/The-sluggish-US-biosimilars-market%20
2. GaBI Online - Generics and Biosimilars Initiative. FDA guidance sought on false and misleading information on biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Mar 20]. Available from: www.gabionline.net/Biosimilars/General/FDA-guidance-sought-on-false-and-misleading-information-on-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. FDA releases guidances and proposed rule to advance biosimilars policy framework [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Mar 20]. Available from: www.gabionline.net/Guidelines/FDA-releases-guidances-and-proposed-rule-to-advance-biosimilars-policy-framework
4. GaBI Online - Generics and Biosimilars Initiative. FDA issues final guidance on petitions delaying generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Mar 20]. Available from: www.gabionline.net/Guidelines/FDA-issues-final-guidance-on-petitions-delaying-generics
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