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Positive phase III results for Amgen’s trastuzumab biosimilar

Biotech giant Amgen and partner Allergan announced on 9 September 2017 positive data from a phase III study of their trastuzumab biosimilar (ABP 980) compared to Herceptin (trastuzumab).

Positive phase I results for rituximab biosimilar CT-P10 in patients with rheumatoid arthritis

Rituximab is an established anti-CD20 monoclonal antibody used for the treatment of some haematological cancers and immune-mediated diseases, such as rheumatoid arthritis (RA). CT-P10 (Truxima) is the first biosimilar of the rituximab reference product and was approved in Europe for all licensed RTX indications in February 2017 [1]. A phase I randomized controlled trial (RCT) of CT-P10 versus reference rituximab in patients with active RA demonstrated that the two drugs had equivalent pharmacokinetics after a single course of treatment and that their efficacy, pharmacodynamics, immunogenicity and safety were comparable up to Week 24 [2]. To allow comparison of CT-P10 versus reference rituximab, patients in the same phase I trial received a second course of treatment and were evaluated for efficacy, safety, pharmacokinetics, pharmacodynamics, and other clinical data for up to 72 weeks. These data demonstrate that the clinical profile of CT-P10 is comparable to reference rituximab in patients with RA over an extended treatment duration [3].

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.

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].

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].

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.

Adello Biologics starts phase I trial for pegfilgrastim biosimilar

US-based biosimilars specialist Adello Biologics has started a phase I clinical trial for a biosimilar version of Amgen’s Neulasta (pegfilgrastim).

Biosimilar pegfilgrastim highly similar to Neulasta

Canada-based Apobiologix published analytical results demonstrating the similarity of their pegfilgrastim product to the US reference product, Amgen’s Neulasta (pegfilgrastim) [1].

Real-life data supports efficacy and safety of biosimilar filgrastim

Biosimilars of filgrastim are widely used in the prophylaxis of chemotherapy‐induced (CIN) and febrile neutropenia (FN). However, there are limited observational data on the use of granulocyte colony-stimulating factor (G‐CSF) in non‐Hodgkin’s lymphoma (NHL) and its aggressive subtypes including diffuse large B‐cell lymphoma (DLBCL).