HERTFORDSHIRE, UK and PITTSBURGH, PA, USA and BENGALURU, India I September 21, 2018 I Mylan N.V. (NASDAQ :MYL ) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Fulphila®, a biosimilar to Amgen’s Neulasta® (pegfilgrastim).

The CHMP positive opinion is based upon a review of evidence demonstrating biosimilarity. Data submitted as part of the Marketing Authorization Application included similarity assessment in analytical testing, preclinical and clinical studies that demonstrated biosimilarity to the reference product, Neulasta. The Phase I program in healthy volunteers and Phase III clinical study conducted in breast cancer patients receiving adjuvant and neoadjuvant chemotherapy demonstrated no clinically meaningful differences in terms of pharmacokinetics, pharmacodynamics, safety, efficacy and immunogenicity compared to Neulasta.

The CHMP positive opinion will now be considered by the European Commission. The decision on approval is expected by November 2018.

Fulphila was approved by the U.S. Food and Drug Administration (FDA) earlier this year and is the first FDA-approved biosimilar for Neulasta in the U.S. Regulatory applications for Fulphila also have been submitted in Australia, New Zealand, Canada and several other countries.

Mylan President Rajiv Malik commented: “We are very proud to be a leader in bringing the first wave of biosimilars to the European market and driving greater access to more affordable treatment options for patients living with chronic and life-threatening illness such as cancer. Receiving CHMP positive opinion for our pegfilgrastim biosimilar, Fulphila, is a key milestone in this journey, demonstrating our commitment to patient and healthcare communities across Europe and the strength of our collaboration with Biocon.”

Biocon CEO & Joint Managing Director, Dr. Arun Chandavarkar, said: “CHMP’s decision to recommend approval of Biocon and Mylan’s biosimilar Pegfilgrastim brings us a step closer to offer this high quality, affordable biologic therapy for cancer patients in the EU, having launched this product in the US, earlier this year. It is an outcome of our commitment to enhance access for patients and be a leading global biosimilars player on the back of significant investments in R&D and global scale manufacturing, together with our partner Mylan.”

Neulasta had brand sales of more than $450 million in Europe for the 12 months ending June 30, 2018, according to IQVIA.

About Pegfilgrastim
Chemotherapy-induced febrile neutropenia (FN) causes treatment delays and interruptions and can have fatal consequences. Current guidelines provide recommendations on granulocyte colony-stimulating factors (G-CSF) for prevention of FN when the risk is considered to be high. Pegfilgrastim as an injectable biologic medication is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (GCSF). It serves to stimulate the level of white blood cells (neutrophils). Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils to fight infection in patients undergoing chemotherapy.

About Biosimilars
A biosimilar is a biological medicine highly similar to another already approved biological medicine (the ‘reference medicine’). Biosimilars are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines. The European Medicines Agency (EMA) is responsible for evaluating the majority of applications to market biosimilars in the European Union (EU).  Further information is available on the EMA website here.  

About the Biocon and Mylan Partnership 
Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products. Fulphila is one of 11 biologic and insulin products co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights for the product in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.

About Mylan
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what’s right, not what’s easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which more than 40% of people being treated for HIV/AIDS globally depend. We market our products in more than 165 countries and territories. We are one of the world’s largest producers of active pharmaceutical ingredients. Every member of our more than 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com. We routinely post information that may be important to investors on our website at investor.mylan.com.

About Biocon
Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is India’s largest and fully-integrated, innovation-led biopharmaceutical company. As an emerging global biopharmaceutical enterprise serving customers in over 120 countries, it is committed to reduce therapy costs of chronic diseases like diabetes, cancer and autoimmune. Through innovative products and research services it is enabling access to affordable healthcare for patients, partners and healthcare systems across the globe. It has successfully developed and taken a range of Novel Biologics, Biosimilars, differentiated Small Molecules and affordable Recombinant Human Insulin and Analogs from ‘Lab to Market’. Some of its key brands are INSUGEN® (rh-insulin), BASALOG® (Glargine), CANMAb™ (Trastuzumab), BIOMAb-EGFR™ (Nimotuzumab), KRABEVA ® (Bevacizumab) and ALZUMAb™ (Itolizumab), a ‘first in class’ anti-CD6 monoclonal antibody. It has a rich pipeline of Biosimilars and Novel Biologics at various stages of development including Insulin Tregopil, a high potential oral insulin. For more information, visit our website: www.biocon.com or Follow us on twitter: @bioconlimited

SOURCE: Mylan