The complexities of biosimilars and the regulatory approval process.

Created via the Biologics Price Competition and Innovation Act, the biosimilar class of drugs was conceived as an opportunity to introduce competition for commonly used biologics following loss of patent protection and market exclusivity, similar to the generic paradigm that has helped sustain access and innovation for more than 3 decades. The FDA approves a biosimilar after a manufacturer establishes that the product is highly similar to a previously approved originator biologic reference product without any clinically meaningful differences in safety, purity, and potency. Given the concerns about increasing healthcare costs and this new opportunity to reduce the expense associated with biologics, including many commonly used oncology medications, the use of biosimilars will likely increase as numerous stakeholders, including managed care organizations, begin to implement policies to encourage adoption. As biosimilars are a relatively new class of drugs, clinical, scientific, and regulatory aspects continue to evolve and improve. Understanding those various aspects can improve clinician acceptance and advance the science of biologics and biosimilars. In this report, various factors are addressed to improve the knowledge of biosimilars, including clinical, manufacturing, and cost considerations.

Biosimilars: Implications for health-system pharmacists.

PURPOSE: An update on scientific and regulatory challenges in the rapidly evolving field of biosimilar product development is presented. SUMMARY: The U.S. market for biosimilar products (i.e., highly similar "follow-on" versions of approved biological drugs) is expected to expand with establishment of an expedited-approval pathway for biosimilars similar to that implemented in European Union countries eight years ago. In 2012, the Food and Drug Administration (FDA) published draft guidance clarifying the requirements of the biosimilars approval pathway; although no biosimilar has yet been approved via that pathway, FDA is engaged in ongoing meetings with a number of potential applicants. Due to molecular differences between innovator products and biosimilar versions, biosimilars are highly sensitive to manufacturing changes that can potentially have important safety and efficacy implications. Establishing the interchangeability of biosimilar and innovator drugs may be difficult at first, and it is possible that some biosimilars might not carry all the same indications for which the reference drug is approved. Pharmaceutical cost savings attained through the use of biosimilars are expected to average 20-30%. With several top-selling biologicals likely to lose patent exclusivity by 2020, health systems should prepare for the availability of new biosimilars by addressing formulary management and therapeutic interchange issues, pharmacovigilance and patient safety concerns, and related financial and operational issues. CONCLUSION: Over the coming years, biosimilars will present opportunities for health care organizations to manage the growth of pharmaceutical expenditures. Pharmacists can play a key role in preparing health systems for projected rapid expansion in the use of biosimilars and associated medication-use policy challenges.

Evaluation of the appropriate use of albumin in adult and pediatric patients.

The appropriateness of albumin use and baseline albumin usage patterns were studied. Institutional practice patterns regarding the use of albumin were compared to criteria established by an independent expert panel. Fifty-three institutions, all of which were members of VHA or the University Health-System Consortium, participated in the evaluation. Investigators collected data over an eight-week period from the medical records, pharmacy records, and hospital billing data of adult (18 years of age or older) and pediatric (age 1-17 years) patients for whom albumin was prescribed. Data collected included patient-specific information, the prescribing physician's specialty area, patient location (level of care) when albumin was prescribed, primary reasons for prescribing albumin, and details of albumin use. Data were collected for 1649 adult and 23 pediatric patients. Albumin was prescribed inappropriately in 57.8% and appropriately in 28.2% of adults; appropriateness of use was unknown in 14% of the patients reviewed. The most common indication for albumin use was hypotension/hypovolemia (23.9%), followed by bypass-pump priming (16.3%), intradialytic blood pressure support (9.6%), and serum albumin values less than 2 g/dL (8.6%). Albumin was prescribed inappropriately 100% of the time when used for intradialytic blood pressure support, low serum albumin values, and acute respiratory distress syndrome. The most appropriate use of albumin occurred in patients with postsurgical hypotension and hypovolemia (67.8%), nephrotic syndrome (79.3%), non-hemorrhagic shock (44.3%), hemorrhagic shock (51.9%), and cirrhosis and paracentesis (31.3%). Albumin was inappropriately prescribed for 57.8% of adult patients and 52.2% of pediatric patients. The mean number of total grams used by patients receiving albumin appropriately was similar to those patients inappropriately receiving albumin.