Healthcare Newsletter October 2021
Taking another step towards affordable access to biologic drugs, US FDA granted interchangeability designation to Boehringer Ingelheim’s (BI) adalimumab biosimilar (Cyltezo®). The biosimilar was approved by the US FDA in 2017. This was followed by a patent lawsuit against Abbvie which BI ultimately settled for a 2023 launch, like many other biosimilar candidates in the pipeline. However, BI has now scored an interchangeable designation which makes it a formidable contender against other biosimilars set for launch since it can now be automatically substituted at the pharmacy level.
The interchangeability designation is a landmark achievement for the biosimilars industry since it’s the first monoclonal antibody to have been granted the interchangeability designation. The first biosimilar to be granted interchangeability being insulin analog Semglee®, which we covered in detail in our PharmForward post. The interchangeability designation also grants Cyltezo® one-year of exclusivity, meaning no other interchangeable biosimilar can be launched for up to one year post Cyltezo’s launch.
Humira® was initially launched by Abbvie in a 40mg/ 0.8ml formulation, however, with patent cliff approaching closer, Abbvie launched a high-concentration 40mg/ 0.4ml in a citrate-free formulation which causes lesser pain and requires lower volume administration. The strategy worked in favour of Abbvie since US FDA biosimilarity regulations interpret strength as the concentration of the formulation and a biosimilar must have the same concentration as the reference product, in spite of having the same total drug content (here, 40mg). High-concentration formulation sales increased rapidly in the US, accounting for 66% of US sales in January, 2020. Currently approved biosimilars for adalimumab, including BI’s interchangeable biosimilar are all low-concentration versions and with the market having graduated to the high-concentration version, adoption may be slow in spite of interchangeability.
Both Celltrion and Alvotech are developing a high-concentration adalimumab biosimilars and Alvotech is also aiming for an interchangeability designation in the US market. Alvotech recently announced positive results from a switching study conducted between AVT02, high-concentration adalimumab biosimilar (100mg/ml) and Humira®, which demonstrated no significant differences in clinical efficacy, safety or immunogenicity between the two cohorts. The switching study is to support the regulatory approval as an interchangeable biosimilar.
With regulatory requirements for interchangeability now established and the regulator having more comfort around the same, approval of more interchangeable biosimilars will be facilitated in the near future. This adds on to the series of recent efforts being undertaken by the regulatory agencies and the government to support the development of biosimilars and improve patient access. This adds to the commercial momentum and enhances value realizability on biosimilar investments targeting the US market.