Biosimilars

Switching from originator to biosimilar epoetins appears to be effective and safe

Biosimilars/Research | Posted 04/10/2019

Switching between biological drugs during pharmacological treatment leads prescribers and patients to ask themselves the question: ‘Will it be safe?’. In particular, when switching from an originator to a biosimilar, the belief that this choice is shaped by economic reasons feeds suspicions and controversies.

Positive EMA-CHMP opinion for SC infliximab biosimilar

Biosimilars/News | Posted 27/09/2019

South Korean biotechnology company Celltrion announced on 22 September 2019 that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had recommended for approval the company’s subcutaneous (SC) formulation of its infliximab biosimilar (CT-P13) in patients with rheumatoid arthritis (RA).

Mylan’s insulin biosimilar blocked, but wins patent battle over pegfilgrastim biosimilar

Biosimilars/General | Posted 27/09/2019

Mylan has received a second complete response letter (CRL) from the US Food and Drug Administration (FDA) over its Lantus biosimilar, while a US District Court rules in their favour over their pegfilgrastim biosimilar, Fulphila.

Samsung Bioepis to supply Brenzys to Brazil under production development partnership

Biosimilars/News | Posted 27/09/2019

On 10 September 2019, Samsung Bioepis announced that it had signed a productive development partnership (PDP) with Brazil’s Ministry of Health to supply Brenzys, a similar biotherapeutic product to rheumatoid arthritis treatment Enbrel (etanercept), to Brazil for the next 10 years.

Switching from originator infliximab to CT-P13: real-world data with 24 months of follow up

Biosimilars/Research | Posted 27/09/2019

A prospective observational study with moderate-to-severe Crohn’s disease (CD) and ulcerative colitis (UC) patients switched from infliximab to CT-P13 treatment was carried out at Hospital Universitario Virgen Macarena, Seville, Spain, and reviewed up to 24 months. The primary endpoint was to analyse the loss of response to infliximab after switching. A loss of response was considered as the Harvey–Bradshaw (HB) index >4 for CD, partial Mayo score (PMS) >2 for UC, steroid use or surgery related to the activity of the disease and/or infliximab dose increase during the follow up.

Trastuzumab biosimilar Herzuma approved in Canada

Biosimilars/News | Posted 20/09/2019

South Korean biotechnology company Celltrion announced on 10 September 2019 that Health Canada had approved its trastuzumab biosimilar Herzuma.

UnitedHealthcare to preferentially cover Amgen’s anticancer biosimilars

Biosimilars/General | Posted 20/09/2019

The largest insurer in the US, UnitedHealthcare, has announced it will preferentially cover Amgen’s biosimilar cancer treatments from 1 October 2019.

China approves new formulation of etanercept copy biological Yisaipu

Biosimilars/News | Posted 20/09/2019

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has approved Yisaipu, an etanercept copy biological as a pre-filled syringe.

Screening protein surface biosimilarity of rituximab using aptamers

Biosimilars/Research | Posted 20/09/2019

Among the many features needed to prove sufficient biosimilarity to a licensed drug produced in living organisms, is coherency of the three-dimensional structure. The integrity thereof is vital for the efficacy and safety of a biopharmaceutical, and even small and local structural changes may result in loss of function or cause undesired side effects for the patients. Reliable assessment of the detailed three-dimensional structure, however, requires laborious analytical methods like Nuclear Magnetic Resonance (NMR) or X-ray crystallography. Another option, epitope characterization using antibodies specific for the target biologicals, is restricted by the availability of appropriate, well-characterized antibody panels and typically involves animal experiments.

Canadian IBD charity updates biosimilar position statement

Biosimilars/General | Posted 13/09/2019

On 5 September 2019, Crohn’s and Colitis Canada announced that it had updated its position statement on the use of biosimilars for inflammatory bowel disease (IBD). The updated position statement was published after the organization reviewed its position on biosimilars particularly related to non-medical switching policy.

Herzuma gains Japanese approval for three-week cycle method

Biosimilars/News | Posted 13/09/2019

South Korean biotechnology company Celltrion announced at the end of August 2019 that Japan's Ministry of Health, Labour and Welfare (MHLW) had approved a three-week cycle method for its trastuzumab biosimilar, Herzuma (CT P6), in the treatment of breast cancer.

More positive phase III results for rituximab biosimilar ABP 798

Biosimilars/Research | Posted 13/09/2019

Biotech giant Amgen, and its partner Allergan, announced on 22 August 2019 positive data from a ‘top-line’ phase III study of its rituximab biosimilar (ABP 798) compared to Rituxan (rituximab) in non-Hodgkin's lymphoma (NHL) patients.

Clinical comparability between rituximab biosimilar RTXM83 and rituximab in diffuse large B-cell lymphoma patients

Biosimilars/Research | Posted 13/09/2019

The arrival of biosimilars represents more affordable alternatives for patients in several countries, increasing their access to costly biological treatments [1]. The positive impact of biosimilars on the financial sustainability of healthcare systems has been recognized by several haemato-oncological societies.

Revance Therapeutics focus on its own Botox biosimilar as work with Mylan is stalled

Biosimilars/News | Posted 13/09/2019

As Revance gives Mylan more time to decide whether to develop their joint Botox biosimilar, the firm is continuing to focus on its own Botox biosimilar, DAXI. It aims to launch the product in 2020.

Teriparatide biosimilar Terrosa launched in Europe

Biosimilars/News | Posted 06/09/2019

Hungary-based Gedeon Richter (Richter) announced on 20 August 2019 that it had launched its teriparatide biosimilar Terrosa in Europe immediately following the patent expiry of the reference product in August 2019.

Switching from reference to biosimilar infliximab in ankylosing spondylitis patients

Biosimilars/Research | Posted 06/09/2019

Ankylosing spondylitis (AS) is a chronic inflammatory rheumatic disease that affects the spine and the sacroiliac (SI) joints. AS is a type of seronegative spondyloarthropathy [meaning that tests show no presence of rheumatoid factor (RF) antibodies] or axial spondyloarthritis (SpA), i.e. it is a chronic, autoinflammatory disease predominantly affecting the axial skeleton [1].

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