Biosimilars
Strategies of players on the global biopharmaceutical market
With many expensive and high-selling biologicals losing patent protection and other exclusivity rights, biosimilars of these molecules may now enter the market, resulting in a shift of market shares, revision of strategies of companies and attraction of new players to the biopharmaceutical market.
EC approval for three rituximab biosimilars
On 13 July 2017, three rituximab biosimilars, Blizima, Rituzena (previously Tuxella) and Ritemvia, received European Commission (EC) approval.
Boehringer Ingelheim starts phase III interchangeability trial for adalimumab biosimilar
Germany-based Boehringer Ingelheim Pharmaceuticals (Boehringer Ingelheim) announced on 27 July 2017 that the first patient had been enrolled into the phase III VOLTAIRE‑X interchangeability study of its adalimumab biosimilar (BI 695501). The company says the trial ‘is the first study in the US to investigate an interchangeability designation for an adalimumab biosimilar candidate’.
Biological drug evolution: improved awareness and pharmacovigilance required
The safety profile of established biological drugs can alter over time following changes to manufacturing processes. However, healthcare professionals are often unaware of changes and there is a need for improved pharmacovigilance, according to a report published by researchers in Scotland, UK [1].
FDA approves adalimumab biosimilar Cyltezo
On 25 August 2017, the US Food and Drug Administration (FDA) approved its second biosimilar version of AbbVie’s Humira (adalimumab).
Australia’s TGA consults on naming of biologicals
Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), announced on 28 July 2017 that it was opening a consultation on how to name biologicals.
Rituximab biosimilar CT-P10 could save Europe Euros 90 million in its first year
A recent publication in Advances in Therapy suggests that introducing CT-P10, a biosimilar of the anti-CD20 monoclonal antibody rituximab, would generate significant savings for European healthcare systems [1]. CT-P10 is approved by the European Medicines Agency (EMA) for all indications held by reference rituximab, including rheumatoid arthritis and haematological cancers, such as non-Hodgkin’s lymphoma and chronic lymphocytic leukaemia. Although the therapeutic benefits of anti-CD20 therapy are well established, the cost of reference rituximab is thought to create barriers to patient access [2]. It is hoped that the introduction of more affordable biosimilars will help address this issue. Gulácsi L et al. therefore quantified the potential budgetary impact of introducing CT-P10 for the treatment of rheumatoid arthritis and CD20-positive cancers in 28 European countries [1].
Biological drug evolution: inadequate short-term clinical trials
The safety profile of established biological drugs can alter over time following changes to manufacturing processes and short-term clinical trials fail to isolate adverse events, according to a report published by researchers in Scotland, UK [1].
EC approval for adalimumab biosimilar Imraldi
Samsung Bioepis announced on 25 August 2017 that it had received European Commission (EC) approval for its biosimilar adalimumab product Imraldi.
Barriers to the market access of biosimilar monoclonal antibodies
In September 2013, the first biosimilar monoclonal antibody (mAb) was approved by the European Medicines Agency (EMA), i.e. biosimilar infliximab (Inflectra/Remsima). These products entered the European market in 2015, after expiry of patent and other exclusivity rights of the innovator medicine Remicade. With the ever-increasing cost of health care and the economic pressure to reduce or sustain healthcare expenses, biosimilars could be instrumental in reducing cost for medication and increasing patient access to treatment. Although exclusivity rights of multiple mAbs are expired (rituximab in 2013, trastuzumab in 2014), only recently biosimilar mAbs other than infliximab are receiving marketing authorization (rituximab, adalimumab). Furthermore, earlier biosimilars have seen slow uptake in European markets. This may imply that several barriers hinder market access of biosimilar mAbs.
