Development and manufacturing of biosimilars has already been discussed as being a surmountable hurdle. The remaining barriers to market entry for biosimilars include the US law and the timing of patent expiries.

• US biosimilars law

The US now has a legal pathway for biosimilars with the approval of the Biologics Price Competition and Innovation [BPCI] Act. However, practical guidance is still being worked on by FDA.

While doubts have been expressed over whether the biosimilars pathway in the US will ever be used [2, 3]. However, Dr Ronny Gal, Sanford Bernstein analyst, believes that although flawed, the biosimilars pathway via the BPCI is likely to become a functioning legal pathway [4].

• Patent expiries

Twelve biological products are expected to be exposed to biosimilar competition by 2020, accounting for US$23 billion in EU sales, and US$29 billion in US sales.

Biosimilar market profitability

Bernstein Research expects that five years after launch, most biosimilar markets will look similar to generics, with biosimilars taking a 70% market share and being priced at 25% of the originator product. However, they admit that a ‘brand-like’ market with lower price reductions and lower market share for biosimilars is also possible. Under the brand and generic scenarios, biosimilar industry revenues will reach US$7–8 billion and operating profits US$2.5–3 billion by 2020. The impact of biosimilars would thus be significant in generics companies portfolios.

The series of three articles that follow attempts to answer outstanding questions regarding the US biosimilars law, the impact of patent expiries and the profitability of biosimilars by giving a brief overview of the remaining barriers to biosimilars entry.

Related articles

The US biosimilars law may prove a barrier to entry for biosimilars

How cheap will biosimilars need to be

The market for biosimilars

Development of biosimilars

Manufacturing of biosimilars

Challenges ahead for biosimilar development

EGA meeting London 2011: biosimilars competitiveness in the EU

References

1. Gal R. Biosimilars: Reviewing US Law and US/EU Patents; Bottom Up Model Suggests 12 Products and $7-$8B Market by 2020. Bernstein Research. 26 May 2011.

2. GaBI Online - Generics and Biosimilars Initiative. US biosimilars pathway unlikely to be used [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 September 16]. Available from: www.gabionline.net/Guidelines/US-biosimilars-pathway-unlikely-to-be-used

3. GaBI Online - Generics and Biosimilars Initiative. Questions over US biosimilars pathway in light of Teva’s BLA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 September 16]. Available from: www.gabionline.net/Biosimilars/General/Questions-over-US-biosimilars-pathway-in-light-of-Teva-s-BLA

4. GaBI Online - Generics and Biosimilars Initiative. US biosimilars pathway unlikely to be used [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 September 16]. Available from: www.gabionline.net/Biosimilars/Research/Biosimilar-regulatory-issues