The U.S. House passed two bipartisan Senate bills April 14 aimed at lowering prescription drug prices through competition. The Advancing Education on Biosimilars Act “improves awareness for the doctor, and the patient, that these drugs are effective and they’re less expensive. They’re good for your health. They’re good for your wallet,” said Sen. Bill Cassidy (R-La.), one of the sponsors of the two bills that will become law once the president signs them. Greater awareness is expected to improve the uptake of biosimilars, increasing biologic competition and lowering the price of expensive drugs. The Ensuring Innovation Act, the second bill on its way to becoming law, is intended to close the loopholes that currently allow sponsors to claim new drug market exclusivity for drugs that aren’t truly innovative, thus delaying generic competition.
WHO: Antibiotic pipeline nearly static
Although 43 antibiotics are in clinical development, none of them sufficiently addresses the problem of drug resistance in the world’s most dangerous bacteria, the World Health Organization’s (WHO) said April 15 as it released its annual Antibacterial Pipeline Report. The 2020 report revealed “a near static pipeline” with only a few antibiotics approved by regulators in recent years; 82% of those products were derivatives of existing antibiotic classes with well-established drug resistance. For the first time, the annual report provides an overview of nontraditional antibacterials, highlighting 27 such agents in the pipeline that range from antibodies to bacteriophages and therapies that support the patient’s immune response and weaken the effect of the bacteria. While some promising products are in development, only a few of them will make it to market due to the economic and inherent scientific challenges that are part of the drug development process, the WHO said. Those challenges, coupled with the small return on investment from antibiotics, has limited the interest of major private investors and most large pharma companies, the organization added.
Canada creates new drug safety net
The Canadian government established a critical drug reserve as an additional safety net to ensure the supply of key drugs that hospitals rely on to treat patients who are critically ill with COVID-19 and that are at risk of shortage. In setting up the reserve, Canada is procuring an initial three-month supply of 12 drugs, including dexamethasone, an antibiotic, a bronchodilator, pain drugs, sedatives, vasopressors and neuromuscular blockers. As of early this month, the government had awarded more than $26 million in contracts to Canadian pharma companies for drugs in the reserve. The costs of those drugs will be shared with participating provinces and territories.
CDSCO provides guidance on COVID-19 vaccines
India’s Central Drugs Standard Control Organization (CDSCO) released guidance April 15 permitting the emergency use in India of COVID-19 vaccines that have been approved for restricted use in the EU, Japan, U.K. or U.S. or that are included on the WHO’s Emergency Use Listing. However, before rolling out a vaccine for broad use in India, the applicant must first monitor the first 100 recipients of the vaccine for seven days for safety outcomes. An applicant also must begin a post-approval bridging trial within 30 days of the vaccine’s emergency approval in India. Applications may be submitted by foreign manufacturers through their Indian subsidiary or through an authorized agent in India. In a separate pandemic-related action this week, CDSCO extended, through Oct. 31, its permission for the import of drugs with a residual shelf life of less than 60%.