biosimilars Archives - Medical Design Sourcing

A robotic arm transfers Humira pens from the conveyor to two-pack cartons. [Image from AbbVie]

The generic and biosimilar company Sandoz, a Novartis (NYSE:SIX) subsidiary, has received FDA approval for its Humira biosimilar Hyrimoz (adalimumab-adaz) injection. AbbVie’s (NYSE:ABBV) megablockbuster Humira is a biologic medication with indications for an array of autoimmune conditions, including rheumatoid arthritis, Crohn’s disease and psoriasis. Sandoz’s biosimilar will likely be priced significantly lower than Humira’s. This fact could dramatically impact the marketplace for AbbVie’s version of the drug, as it is priced lower and could lead to a decrease in market share for Humira.

The FDA approved Sandoz’s Hyrimoz, a biosimilar of AbbVie’s Humira, to treat seven conditions: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis,…

Image courtesy of Central Research Laboratories

Life science products like pharmaceuticals, biologics and biosimilars that feature active pharmaceutical ingredients (APIs) require the safe, efficient, contamination-free, i.e., “aseptic,” handling of raw materials and finished products. Maintaining a sterile production process demands that all components used in a cleanroom or isolator be kept contaminant-free. Beta bags play a critical role in this process, but before selecting a beta bag brand or model, the aseptic-process operator should consider four things:

1. What is the main purpose of beta bags?

Alpha ports (sealed openings) used in cleanrooms and isolators give operators access to various components during an aseptic-production process, allowing the operator to retrieve items ranging from vial stoppers to syringe plungers, hand wipes to cable ties, and simple pen and paper. Contamination-free access …

biosimilars

Sandoz’s Hyrimoz to challenge AbbVie’s Humira dominance

4 things to keep in mind when selecting beta bags