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While retail prices for generic cancer drugs may be the highest in the U.S., these medicines aren’t necessarily affordable in poorer countries such as India and China despite their lower prices, according to a study. Read More
Drugmakers submitting ANDAs for products using transdermal delivery systems are expected to demonstrate that they made “reasonable efforts” to optimize the adhesive characteristics of their patches, the FDA says. Read More
Biopharmaceutical firm Biocad has filed suit against Roche and its Genentech subsidiary over their alleged use of predatory pricing practices in Russia to decimate the sales of the Russian drugmaker’s biosimilars. Read More
Generic trade groups and patient advocacy organizations are taking competing stances in their recommendations for the FDA’s biosimilar labeling draft guidance. Read More
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