Showing MVASI is Highly Similar to Avastin® (Bevacizumab)Marketing Authorization Based on Global Development Program 

First biosimilar bevacizumab approved in the European Union

Amgen (NASDAQ: AMGN) and Allergan plc. (NYSE: AGN) announced in January that the European Commission (EC) has granted marketing authorization for MVASI® (biosimilar bevacizumab). MVASI is the first biosimilar bevacizumab approved by the EC and is approved for the treatment of certain types of cancers, including in combination with fluoropyrimidine-based chemotherapy for metastatic carcinoma of the colon or rectum; in combination with paclitaxel for metastatic breast cancer; in combination with platinum-based chemotherapy for unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC); in combination with erlotinib for unresectable advanced, metastatic or recurrent non-squamous NSCLC; in combination with interferon alfa-2a for advanced and/or metastatic renal cell cancer; in combination with carboplatin and paclitaxel, carboplatin and gemcitabine, and paclitaxel, topotecan, or pegylated liposomal doxorubicin for advanced, platinum-sensitive, or platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer; and in combination with paclitaxel and cisplatin, or alternatively, paclitaxel and topotecan for persistent, recurrent, or metastatic carcinoma of the cervix.

“The European Commission’s approval of MVASI marks a significant milestone for both Amgen and the oncology community, providing a biosimilar for a medicine which is used across multiple types of cancer”, said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “MVASI is the first targeted cancer biosimilar from Amgen’s portfolio approved in Europe, underscoring our commitment to delivering high-quality medicines that address some of the most serious illnesses.”

Amgen and Allergan are committed to developing high-quality biosimilars with a robust analytic and clinical package. The EC approved MVASI® based on a comprehensive data package that demonstrated MVASI® and bevacizumab are highly similar, with no clinically meaningful differences in terms of the efficacy, safety and immunogenicity between the products.

Clinical studies included results from a phase 3 trial in patients with non-squamous NSCLC.

“MVASI® is the first product from our collaboration with Amgen to receive marketing authorization from the European Commission, highlighting the success of our joint commitment to developing cancer biosimilars”, said David Nicholson, chief research and development officer at Allergan. “We look forward to our continued work with Amgen and to providing important medicines to patients in the future.”

Approval from the EC grants a centralized marketing authorization with unified labeling in the 28 countries that are members of the European Union (EU). Norway, Iceland and Liechtenstein, as members of the European Economic Area, will take corresponding decisions on the basis of the decision of the EC.

In September 2017, MVASI® became the first anti-cancer biosimilar, as well as the first biosimilar bevacizumab, to be approved by the U.S. Food and Drug Administration (FDA). Amgen and Allergan are collaborating on the development and commercialization of four oncology biosimilars. Amgen has a total of 10 biosimilars in its portfolio, two of which have been approved by the EC.

About MVASI® (biosimilar bevacizumab) in the EU

MVASI® is a biosimilar to bevacizumab, a recombinant immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that binds to vascular endothelial growth factor (VEGF) and inhibits the interaction of VEGF with its receptors, VEGF receptor-1 and VEGF receptor-2, thus inhibiting establishment of new blood vessels necessary for the maintenance and growth of solid tumors.

MVASI®, in combination with fluoropyrimidine-based chemotherapy, is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.

MVASI®, in combination with paclitaxel, is indicated for first-line treatment of adult patients with metastatic breast cancer.

MVASI®, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent NSCLC other than predominantly squamous cell histology.

MVASI®, in combination with erlotinib, is indicated for the first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous NSCLC with Epidermal Growth Factor Receptor (EGFR) activating mutations.

MVASI®, in combination with interferon alfa-2a, is indicated for first-line treatment of adult patients with advanced and/or metastatic renal cell cancer.

MVASI®, in combination with carboplatin and paclitaxel, is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics [FIGO] stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.

MVASI®, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for the treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.

MVASI®, in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin, is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.

MVASI®, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.

MVASI® EU important safety information

The EU Summary of Product Characteristics for MVASI lists the following Special Warnings and Precautions: gastrointestinal (GI) perforations and fistulae, GI-vaginal fistulae in study GOG-0240, non-GI fistulae, wound healing complications, hypertension, posterior reversible encephalopathy syndrome (PRES), proteinuria, arterial thromboembolism, venous thromboembolism, hemorrhage, pulmonary hemorrhage/hemoptysis, congestive heart failure (CHF), neutropenia and infections, hypersensitivity reactions/infusion reactions, osteonecrosis of the jaw (ONJ), intravitreal use, eye disorders, systemic effects following intravitreal use, and ovarian failure/fertility.