CelltrionHealthcare

Barriers to uptake of biosimilars in oncology and how to overcome these were discussed in the context of the introduction of biosimilar trastuzumab for the treatment of breast cancer

22 October 2018 – To coincide with the ESMO 2018 Congress in Munich, Germany, Celltrion Healthcare invited perspective from experts including a physician and pharmacist to provide information to patient advocacy groups on the history of biosimilars, how they are tested and approved, their cost saving benefit and the wealth of clinical evidence already available on their use in order to improve understanding of biosimilars.

The introduction of biosimilars in the treatment of cancer has the potential to reduce pressure on healthcare budgets and increase access to other innovative treatments or more potent regimens. This is achieved by offering more cost-effective alternatives to the reference medicinal products and by increasing competition in the market.

Breast cancer is the most common cancer in women worldwide and accounts for a quarter of all cancer diagnoses in women.[1] For the benefits of biosimilar use to be realised in oncology, and in the treatment of breast cancer, barriers to their uptake need to be addressed. Some of the barriers include, lack of familiarity in prescribing biosimilars amongst oncologists and low understanding of what biosimilars are amongst patients.

Oncologists and oncology nurses need to be better educated about biosimilars, the development process and the steps in the regulatory pathway to feel confident in prescribing and administering them and to provide well-informed advice and support to their patients.

The regulatory process for biosimilars is significantly more advanced than that for generics with trials assessing safety and efficacy required alongside pharmacodynamic and pharmacokinetic studies, although this is not widely understood.

The introduction of biosimilars in oncology can benefit patients by allowing access to new innovative treatments that would otherwise not be cost-effective. Patients can be concerned by changes to their treatment so must be well informed about their treatments and understand the rationale for any switch to biosimilars.

As the wealth of experience of biosimilars has built up, confidence in their use has increased. Professional groups such as the American Society of Clinical Oncology (ASCO) and the European Society for Medical Oncology (ESMO) both recognise the benefits of biosimilars in oncology care and have published guidance on their use and value.

“The perception of biosimilars amongst stakeholders has changed positively as more evidence has become available,” said Prof. Stebbing, Faculty of Medicine, Department of Surgery and Cancer, Imperial College London. “Professional groups such as ESMO recognise the opportunity biosimilars provide in obtaining optimal clinical outcomes whilst controlling the cost of cancer treatments. Guidance from groups such as these gives physicians confidence to prescribe them”.

“We are at a turning point in the use of biosimilars as the benefit they bring to healthcare systems is beginning to be universally recognised,” said Mr HoUng Kim, Head of Strategy and Operations Division, Celltrion Healthcare. “This needs to be replicated in the field of oncology, so we can ensure patients worldwide can get access to new treatment regimens through the use of high quality, more cost-effective biosimilars”.

--- Ends---

Notes to editors:

About Herzuma^® (CT-P6, biosimilar trastuzumab)

CT-P6 is a monoclonal antibody (mAb) – a protein designed to recognise and bind to a specific structure or antigen in the body. CT-P6 has been designed to bind with high affinity and specificity to the extracellular domain of human epidermal growth factor receptor (HER2).

HER2 is found to be overexpressed and/or amplified in about 15-20% of patients with the diseases for which reference trastuzumab is indicated. By binding toHER2 receptor binding domains on the tumor cells, trastuzumab inhibits proliferation of HER2 overexpressing tumour cells.

Celltrion has carried out extensive studies between CT-P6 and reference trastuzumab to establish that they are highly similar in physicochemical and biological attributes. Studies have also demonstrated comparability in terms of efficacy, pharmacokinetics, pharmacodynamics, immunogenicity and safety.

Herzuma^® is a biosimilar to Herceptin^®[2], a biologic drug developed by Genentech and marketed by Roche. Herceptin^® is a blockbuster drug which had worldwide sales of CHF 6.8 billion (US$6.8billion) in 2016, of which CHF 2.1 billion (US$2.1 billion) was in European sales. [3]

CT-P6 is also currently under review by the FDA but not yet an approved product in the U.S.

About Celltrion Healthcare

Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Remsima^®/ Inflectra^®(CT-P13, biosimilar infliximab) which is the world’s first monoclonal antibody (mAb) biosimilar, received EMA and FDA approval, respectively. Truxima^® (CT-P10, biosimilar rituximab) and Herzuma^® (CT-P6, biosimilar trastuzumab) received EMA approval. Celltrion Healthcare’s products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavors to offer high-quality cost-effective solutions through an extensive global network that spans more than 120 different countries. For more information please visit:http://www.celltrionhealthcare.com/

References