Generics lobby group establishes biosimilars arm
This article was originally published in Scrip
The Generic Pharmaceutical Association (GPhA) on 16 April launched a new division concentrated on the biosimilars industry.
GPhA said its Biosimilars Council will work to ensure a "positive regulatory, reimbursement, political and policy environment for patient access to biosimilar medicines and will educate the public and patients about the safety and effectiveness of biosimilars."
Areas of focus for GPhA's new biosimilars arm will include education, access, the nascent regulatory environment, reimbursement and legal affairs.
"In addition to being a voice with policymakers, this new division will be an invaluable partner for patients, providers, manufacturers, consumer groups and stakeholders from all corners of the supply chain seeking to stay apprised of critical developments regarding biosimilars," said GPhA chairman Craig Wheeler, president and CEO of Momenta Pharmaceuticals.
So far, only one biosimilar has been approved in the US – Zarxio (filgrastim-sndz), from Novartis and its Sandoz unit.
But other firms have applications before the FDA, including Apotex's version of filgrastim and its biosimilar of Amgen's Neulasta (pegfilgrastim); Hospira's epoetin alfa version of Amgen's Epogen and Johnson & Johnson's Procrit; and Celltrion's infliximab biosimilar of J&J's Remicade.
GPhA's Biosimilar Council also released an educational handbook on 16 April, The Next Frontier for Improved Access to Medicines: Biosimilars and Interchangeable Biologic Products, which the group said explains the benefits and science behind biosimilar medicine, who will benefit from access to the products, the legal and regulatory framework and the quality manufacturing and development process.