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Home » BI Petitions FDA to Change Interpretation of the Word ‘Strength’ to Level Playing Field for Biosimilars
BI Petitions FDA to Change Interpretation of the Word ‘Strength’ to Level Playing Field for Biosimilars
Boehringer Ingelheim (BI) Pharmaceuticals has filed a petition with the FDA arguing that the agency’s use of the word “strength” squelches competition from makers of biosimilars and runs afoul of FDA’s Biologics Price Competition and Innovation Act (BPCIA). The company has asked the FDA to change its interpretation of the word.