Biosimilars

Celltrion/Teva launch trastuzumab biosimilar Herzuma in US

Biosimilars/News | Posted 27/03/2020

Celltrion and Teva announced in March 2020 that they have launched their trastuzumab biosimilar Herzuma (trastuzumab-pkrb) in the US. Herzuma can be used to treat breast and gastric cancer and has recently been approved in Canada [1].

Clover starts phase III trial for etanercept copy biological in China

Biosimilars/Research | Posted 27/03/2020

At the end of December 2019, Clover Biopharmaceuticals (Clover), a Chinese company focused on biological therapies, announced the start of a phase III trial of their etanercept copy biological (SCB-808), a proposed copy biological to originator biological Enbrel (etanercept).

US oncologist says Medicare should not practice medicine

Biosimilars/General | Posted 27/03/2020

Clinical oncologist, Dr Debra Patt, who serves on the US Oncology Research Breast Cancer Committee and chairs the breast cancer subsection of the pathways task force for The US Oncology Network, expresses her opinion on a new policy introduced by Medicare, which she believes is ‘having a negative impact on a patient’s outcome’.

Positive phase I results for Qilu’s bevacizumab copy biological

Biosimilars/Research | Posted 20/03/2020

Positive results were reported from a phase I trial of a bevacizumab copy biological, QL1101, which the authors say is ‘the first study to compare the pharmacokinetics of QL1101, a proposed bevacizumab [copy biological], with Avastin’ [1].

Celltrion launches infliximab biosimilar Remsima SC in Europe

Biosimilars/News | Posted 20/03/2020

In a successful time for Celltrion Healthcare (Celltrion), the company has launched their infliximab biosimilar Remsima in Germany and the UK.

PK and PD similarity between pegfilgrastim biosimilar and Neulasta

Biosimilars/Research | Posted 20/03/2020

Hexal AG has published phase I results for its approved pegfilgrastim biosimilar [1-3].

FDA and FTC collaborate to deter anti-competitive behaviour for biologicals

Biosimilars/General | Posted 20/03/2020

The US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) announced on 3 February 2020 that they would enhance their collaboration when it comes to anti-competitive behaviour in the biologicals’ marketplace.

Arguments against Alberta’s plans to switch patients to biosimilars

Biosimilars/Research | Posted 13/03/2020

In May 2019, the Canadian province of British Columbia introduced a policy of switching rheumatology patients to biosimilars [1]. Now, the province of Alberta is also considering plans to stop coverage of originator biologicals and switch patients to biosimilars for certain indications. The new policy, if introduced, will apply to the approximately 30,000 patients in Alberta living with inflammatory bowel disease (IBD) [2].

Amgen starts phase III trial for aflibercept biosimilar

Biosimilars/News | Posted 13/03/2020

US-based biotech giant Amgen is initiating a phase III clinical trial for a biosimilar of Regeneron’s Eylea (aflibercept).

FDA publishes historic drug approvals and searchable Purple Book

Biosimilars/General | Posted 13/03/2020

The US Food and Drug Administration (FDA) has released a dataset of drug approvals dating back to 1985 and an online, searchable version of the Purple Book of licensed biologicals.

Tackling the challenge of safe automatic substitution of biologicals

Biosimilars/Research | Posted 13/03/2020

The costs of biologicals are challenging the sustainability of pharmacotherapy. Affordable biosimilars are expected to trigger competition within the biologicals market. Increasing real-world experience on biosimilars and clinical switching studies have led to position papers supporting the interchangeability of biosimilars with their reference products under the supervision of the prescriber [1]. However, the uptake of biosimilars has been poor in Finland, since physicians have been reluctant to prescribe biosimilars, especially in the outpatient setting. One option to stimulate the uptake of biosimilars is the automatic substitution of biologicals at the pharmacy level.

Biosimilars in the age of patient-centricity

Biosimilars/Research | Posted 06/03/2020

In 2020, nearly all pharmaceutical companies claim to be ‘patient-centric’. In fact, some companies have even initiated processes of designing new treatments ‘around the patient’ and convened ‘Patient Advisory Boards’ to ensure patients provide their input into clinical trial design. In addition, though to a lesser extent, some have also developed educational programmes to ensure clinicians and patients truly understand the use and function of biosimilars. Regulators have also participated in the effort to ensure that patients consent to be prescribed biosimilar treatments and are well informed of their relative risks and benefits. President of the French Association of Pharmaceutical Medicine, Dr Francois-Xavier Frapaise, discusses how these latest ‘patient-centric’ efforts affect patients [1].

FDA accepts application for Mylan’s bevacizumab biosimilar

Biosimilars/News | Posted 06/03/2020

US-based drugmaker Mylan announced on 27 February 2020 that the US Food and Drug Administration (FDA) had accepted its application for its bevacizumab biosimilar (MYL 1402O).

Ontario becomes third Canadian province to switch patients to biosimilars

Biosimilars/General | Posted 06/03/2020

In Canada, the province of Ontario has followed Alberta and British Columbia in introducing a policy to switch certain patients to biosimilars.

Positive results for Bio-Thera’s bevacizumab copy biological

Biosimilars/Research | Posted 28/02/2020

China-based Bio-Thera Pharmaceuticals (Bio-Thera) announced positive results from a phase III trial of its bevacizumab copy biological.

Reasons and solutions for the high cost of insulin in the US

Biosimilars/Research | Posted 21/02/2020

The most commonly used forms of analogue insulin cost 10 times more in the US than in any other developed country. In fact, the cost of insulin in the country has more than tripled in the past 10 years [1]. This has led to patients rationing their insulin; something that does not happen in other developed countries, but is common in the US.

Bio-Thera launches first adalimumab copy biological in China

Biosimilars/News | Posted 21/02/2020

Bio-Thera Solutions (Bio-Thera) announced in January 2020 the launch of the first adalimumab copy biological in China. The drug can be used to treat rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis and will be marketed as Qletli.

Mylan launches anti-cancer biosimilar in the US

Biosimilars/News | Posted 21/02/2020

The US drug market receives a new oncology biosimilar as Mylan launches its trastuzumab biosimilar, Ogivri.

Mylan launches anti-cancer biosimilar in the US

Pfizer launching biosimilars in US and Japan but not in EU

Biosimilars/News | Posted 14/02/2020

In early 2020, pharma giant Pfizer announced that it was launching its rituximab biosimilar in Japan and that it would be launching three new biosimilars onto the US market.

Relative bioavailability of FKB327 when administered using different methods

Biosimilars/Research | Posted 14/02/2020

FKB327 is a biosimilar of Humira (adalimumab), a recombinant, human immunoglobulin G1 monoclonal antibody specific for human tumour necrosis factor alpha (TNF-α). The European Medicines Agency approved FKB327, as Hulio, in 2018 [1].