New drug approvals and safety information are constantly being released. Staying up-to-date can be a daunting task for family physicians. Several electronic resources provide valuable, concise information directly. It is important to be well informed about new drugs, and drug mechanisms, indications, and administration routes. Pertinent new drug mechanisms include calcitonin gene-related peptide receptor antagonists for migraine prevention, selective inhibitors of influenza cap-dependent endonuclease, and adenosine triphosphate-citrate lyase inhibitors for hypercholesterolemia. Dapagliflozin recently gained approval for heart failure with reduced ejection fraction with or without type 2 diabetes. Newly approved administration routes include oral semaglutide and intranasal esketamine and glucagon. Drug accessibility, cost, and advantages over existing drugs should be considered. Physicians also should search formularies and promptly respond to prior authorization requests. Physicians should be knowledgeable about drug safety updates, such as adverse events and drug recalls. When a drug has been recalled, it is imperative for prescribers to provide accurate patient advice and therapeutic alternatives. Clinical pharmacists are excellent resources for new drug information, formulary and cost savings management, and drug recall navigation.

Case 2. RA is a 43-year-old woman with a history of diabetes, hyperlipidemia, and migraine. She takes extended-release metformin 750 mg 2 times/day, atorvastatin 40 mg/day, propranolol 80 mg/day, and sumatriptan 100 mg orally as needed for migraines. At today’s visit, RA asks you about a commercial she saw for a once-monthly injection to prevent migraines and asks if that might work better or her.

Drug Development Trends

The average number of annual new drugs approved by the Food and Drug Administration (FDA) from 2010 to 2018 was 41, an increase from 34 from 1990 to 1999, and 25 from 2000 to 2009.³³ Between 2011 and 2016, approximately 80% of submitted new drug applications and biologics license applications were approved.³⁴ Over the past decade, approvals for biologics and anticancer drugs have increased. Biologics accounted for 88 approvals between 2008 and 2018, representing 29% of new drug approvals in 2018.³³

Approvals of new generics and biosimilars also are important given their significant cost savings for patients. The annual number of generic drug approvals has increased substantially since 1994 despite the annual number of new drug approvals remaining steady.³³ For approval, the generic does not need to show clinical efficacy, only similar pharmacokinetics to the initial drug. Generic drugs and biosimilars are similar chemical entities to an approved biologic. However, the molecular complexity makes it virtually impossible for a manufacturer to create an identical compound. Bio-similars must show no clinically significant difference in terms of safety, purity, and potency to the original product despite small differences in structure. A follow-on biologic is a biosimilar that has been approved via an older approval pathway. For example, Basaglar is the proprietary name for the follow-on biologic for insulin glargine, originally marketed as Lantus.