Increased demand for a drug is a welcome outcome of gaining regulatory approval and successful marketing. But scaling up production of biologics isn't easy.
After a rocky 2009 for dealmaking, in which big pharma was busy digesting mega mergers and managing bottom-line pressure, biotech companies and investors alike were looking forward to a solid 2010. (See BioWorld Insight, Jan. 25, 2010.)
Earlier this month, the European Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for InterMune Inc.'s idiopathic pulmonary fibrosis (IPF) drug Esbriet (pirfenidone). The European Medicines Agency (EMA) is expected to ratify the decision in a few months, clearing the way for InterMune to launch the drug in Europe. (See BioWorld Today, Dec. 20, 2010.)