For over 18 years, European Pharmaceutical Manufacturer has kept readers informed about the most current news, perspectives, developments, and breakthroughs in every aspect of the pharma/biopharma manufacturing supply chain, from formulation to distribution.
In Europe, just over 20% of all spending on biologics now faces competition from biosimilars. In the United States, just below 20% of the biologics market is exposed to biosimilar competition, with up to 60% of the market holding potential for biosimilar development.
In this article, Darren Mansell, Regulatory Affairs Manager, discusses the regulatory impact of making device modifications in combination products. Find more details on page 21 via the link below.