Accord Healthcare launches generic lenalidomide

Accord one of the first to market generic lenalidomide in the UK, with robust safety protocols in place to safeguard patients

LONDON, Jan. 18, 2022 /PRNewswire/ --

Press release intended for trade and medical press journalists only.

Accord Healthcare today announced the UK launch of generic lenalidomide, available for the treatment of adult patients with multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma and follicular lymphoma, as either a monotherapy or combination therapy^[1]. Accord lenalidomide has been granted Marketing Authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) in line with the licensed indications of the brand originator, Revlimid^®, and is now available for patients throughout the UK in seven dose strengths – 2.5mg, 5mg, 7.5mg, 10mg, 15mg, 20mg, and 25mg^[1]. Accord lenalidomide will launch in further markets across Europe on 18^th February 2022.

Multiple myeloma is a cancer of the plasma cells for which typical survival is seven months without treatment and four to five years with treatment^[2]. There are around 6,000 new myeloma cases in the UK every year, with an increase in incidence rates of a third since the 1990s^[3]. Currently, approximately 24,000 people are living with multiple myeloma in the UK^[4].

Anup Sidhu, Speciality Brands & Hospitals Director, said: "The launch of lenalidomide underlines Accord's continued commitment to improving access to cancer treatments for both patients and the NHS. As with the Accord launch of generic thalidomide early last year, our aim is to introduce price competitiveness to benefit both health systems and patients in accessing this medicine, thereby improving outcomes. Through partnership across the healthcare system, Accord is ensuring robust pregnancy prevention measures are in place for patients prescribed lenalidomide, alongside driving improvements in processes for the NHS."

Lenalidomide is a type of targeted therapy called an angiogenesis inhibitor and a cancer growth inhibitor. It is also a type of immunotherapy called an immune system modulator^[5]. Lenalidomide treatment interferes with chemicals that cells use to signal to each other to grow, and it affects how the immune system works. It also prevents tumours creating their own blood vessels, which all cancers require in order to develop^[6]. However, like thalidomide, it is a powerful human teratogen, which means it can cause severe and life-threatening birth defects and must not be used during pregnancy.

To minimise the risks associated with this treatment, Accord will oversee a robust protection system to support safe prescribing, including a strictly monitored Pregnancy Prevention Programme and an electronic portal for healthcare professional use, facilitating pharmacy registration and prescription authorisation. Alongside Accord's investment in the development of digital technologies to improve the mandatory process that must accompany this medicine, risk minimisation materials are available in a paper-based format to support the differing needs of healthcare professionals.

Accord is a leading player in the generic oncology field, with a portfolio and product development pipeline focused on prevalent tumour types, in addition to haematological and cancer supportive care therapies.

Notes to Editor

Accord's Commitment to the Lenalidomide Pregnancy Prevention Programme

• Like thalidomide, lenalidomide is a powerful human teratogen, which means it can cause severe and life-threatening birth defects and must not be used during pregnancy.
• To minimise the risks associated with treatment, Accord will oversee a strictly monitored Pregnancy Prevention Programme, designed to prevent exposure during treatment in women of childbearing potential. The programme will include the following:
  - Risk minimisation measures for women of childbearing potential, women of non-childbearing potential and for male patients (since lenalidomide can be found in semen).
  - A controlled distribution system which requires pharmacies who wish to dispense lenalidomide to first be registered with Accord-UK and agree to implement the risk minimisation measures.
  - Ongoing assessment of Pregnancy Prevention Programme measures through a Prescription Authorisation Form (PAF) which must be completed by the prescriber and dispensing pharmacist for each prescription of lenalidomide, with a copy sent to Accord-UK to facilitate mandatory audit requirements.

About Accord Healthcare

Headquartered in the United Kingdom, Accord Healthcare is one of the fastest growing pharmaceutical companies in Europe. Accord has one of the largest market footprints of any European generic and biosimilars companies, selling generic medicines in over 80 countries around the world.

This global footprint enables us to deliver vital, affordable medicines to national health systems supporting healthcare professionals to transform patient lives worldwide.

The approach of Accord is agile and inventive, always seeking to improve products and patients' access to them. Accord is driven to think differently and deliver more for the benefit of patients worldwide.

The lenalidomide Accord Summary of Product Characteristics (SmPC) can be found on the electronic medicines compendium (eMC) website: www.medicines.org.uk, and a copy accompanies this press release.

1. Accord Healthcare Ltd. Lenalidomide Accord Summary of Product Characteristics.
2. NCI. Plasma Cell Neoplasms (Including Multiple Myeloma) Treatment (PDQ®) – Health Professional Version. December 2021 https://www.cancer.gov/types/myeloma/hp/myeloma-treatment-pdq#_1 (Accessed January 2022).
3. Cancer Research UK. Myeloma Statistics. https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/myeloma (Accessed January 2022).
4. Myeloma UK https://www.myeloma.org.uk/understanding-myeloma/what-is-myeloma/ (Accessed January 2022).
5. Macmillan Cancer Support https://www.macmillan.org.uk/cancer-information-and-support/treatments-and-drugs/lenalidomide (Accessed January 2022).
6. Cancer Research UK https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/cancer-drugs/drugs/lenalidomide (Accessed January 2022).