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To bridge the gulf between the promise of biosimilars on drug pricing and the reality, payors should incentivize biosimilar utilization, a new report states. Read More
Although it is easy for drugmakers to conflate the terms “biosimilars” and “generics,” it is important for them to realize that they are not one in the same, as the policies governing biosimilars are very different from those governing small molecule drugs, an expert stresses. Read More
An FDA official is taking steps to clarify labeling requirements for generic drugmakers, as frequent deficiencies can lead to increased review cycles and labeling that differs from reference products. Read More
Sponsors with pending ANDAs backed by trials conducted at India’s Semler Research Limited must return to the drawing board because of data integrity issues, the FDA said. Read More
UK regulators have fined Pfizer $14,000 for failing to explain a questionable claim meant to justify price increases on the generic seizure medication Epanutin. Read More
The FDA is proposing to extend review times to enable more communication between the agency and sponsors to increase the number of first cycle approvals for biosimilars. Read More
Drugmakers and trade groups overwhelmingly want lower user fees and a clearer review process for GDUFA as the FDA looks to renew the user fees before the Sept. 30, 2017 cut-off date. Read More
Generic drug applicants need to get their bioanalytics right when demonstrating bioequivalence to avoid costly delays or outright rejection by the FDA, an agency official warns. Read More
Members of the Senate Special Committee on Aging took Valeant Pharmaceuticals’ International officials to task over what they called the company’s practice of buying drugs with no generic competition and “jacking up” the prices. Read More
The House Appropriations Committee passed a fiscal 2017 agricultural appropriations bill in April that proposes a slight funding increase for the FDA, but still remains well below the agency’s funding request. Read More
The Office of Generic Drugs had a banner year in 2015, seeing more than 700 full and tentative approvals, the agency announced in April in its first-ever report on generics. Read More