Genetic Engineering & Biotechnology News

MAY15 2018

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D community with critical information on the tools, technologies, and trends that drive the biotech industry.

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Genetic Engineering & Biotechnology News | | MAY 15, 2018 | 23 and discounts go back to the members or in many cases to the health system," complains Mr. Brook. Savings shortfalls may be due to slow development, approval, and adoption of biosimilars; legal challenges by the reference product manufacturers; negotiations over rebate terms; and payment structures that base benefits on published price and exclude rebates. Such factors could increase costs for beneficiaries over those of the reference prod- uct. "They could," adds Mr. Brook, "make it harder for companies to put their biosimilars into the market." Regulatory Considerations The development and approval of bio- similars raises regulatory and practical con- siderations. The regulatory considerations are becoming defined, thanks to the guide- lines issued by the EMA and the FDA. The practical considerations, however, can be relatively unclear. For pharmacists, practical considerations include naming and labeling issues; logistics and reimbursement practices; and usage standards with respect to inter- changeability, substitution, and indication extrapolation. Both regulatory and practical consider- ations preoccupy James Stevenson, Pharm.D., professor of clinical pharmacy at the Univer- sity of Michigan College of Pharmacy. In his capacity as a pharmacy practitioner and healthcare administrator, Dr. Stevenson fo- cuses on tracking the regulatory process and analyzing how biosimilars are integrated into health systems. For example, Dr. Stevenson is familiar with indication expansion, or the process whereby a biosimilar is approved for an in- dication held by the originator biologic. This process may accommodate a biosimilar that has not been evaluated in clinical trials spe- cifically for the relevant indication. "We are becoming much more comfort- able with the regulatory process and with extrapolation to indications not specifically studied in the biosimilar approval process," comments Dr. Stevenson. Extrapolation is carried out most confidently, he suggests, if it concerns drugs for which the mechanism of action and site of action are well understood. "A trend toward more assured extrapo- lation is reflected in recent statements by medical organizations," asserts Dr. Steven- son. "These organizations have also begun to be more comfortable with the ability to conduct limited switching of patients from a reference product to a biosimilar." To date, over 35 biosimilars have been approved by the EMA, but only nine by the FDA. This discrepancy reflects how bio- similar approvals started relatively late in the United States. In Europe, biosimilar approv- als commenced in 2006. In the United States, they began 10 years later. "In the United States," Dr. Stevenson points out, "we did not even have a legal process to create the regulatory framework until 2010." The number of biosimilars on the U.S. market (only three at this time) has been limited by prolonged U.S. patent is- sues. "It is frustrating that we have approved products that have yet to be marketed prop- erly," complains Dr. Stevenson. A key distinction between the biosimilar space in Europe and in the United States is that the FDA regulatory process contains the designation of an interchangeable biosimilar. "The EMA does not have that designation," informs Dr. Stevenson, "and it is up to the individual countries what their policies are on interchangeability." The FDA designation of interchangeabil- ity, which was established early on, reflects a conservative approach and accounts for the possibility that that a reference product can be substituted with a biosimilar with- out the intervention of the healthcare pro- vider who originally issued the prescription. "While this was well intended," suggests Dr. Stevenson, "as we get more and more data indicating that one can safely switch patients from a reference product to a biosimilar, this might be a barrier that we ultimately might regret." 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A n international research team says it has investigated all approved, investi- gational, and experimental antiviral agents to search for new applications for these substances against existing and emerging viruses. The team's results ("Novel Activities of Safe-in-Human Broad-Spectrum Antiviral Agents") have been published in Antiviral Research. "According to the WHO, there is an urgent need for better control of viral diseases. Re-positioning existing safe-in-human antiviral agents from one viral disease to another could play a pivotal role in this process. Here, we reviewed all approved, investigational, and experimental antiviral agents, which are safe in man, and identified 59 compounds that target at least three viral diseases," write the scientists. "We tested 55 of these compounds against eight different RNA and DNA viruses. We found novel activities for dalbavancin against echovirus 1, ezetimibe against human immunodeficiency virus 1 and Zika virus, as well as azacitidine, cyclosporine, minocycline, oritavancin, and ritonavir against Rift valley fever virus. Thus, the spectrum of antiviral activities of existing antiviral agents could be expanded toward other viral diseases." Powerful Tools Antiviral drugs and vaccines are the most powerful tools to combat viral diseases. Most drugs and vaccines, however, selectively target a single virus, thereby providing a "one drug–one bug" solution, the researchers say. In contrast, broad-spectrum antivirals (BSAs) can cover multiple viruses and genotypes and reduce the likelihood of development of resistance. Therefore, some BSAs can be used for the rapid management of new or drug-resistant viral strains, for a first-line treatment, or for prophylaxis of acute virus infections, as well as for viral co-infections, which can reduce the complexity of treatment. "Repurposing these therapeutics from one viral disease to another could save resources and time," notes Denis Kainov, Ph.D., a researcher from the Norwegian University of Science and Technology (NTNU) and a corresponding author of the study. The researchers assert their results show that existing safe-in-human antivi- rals could be used in different viral infections. The goal: Create BSAs that would be analogous to the broad-spectrum antibacterial drugs that are already available. "Effective treatment with BSAs may shortly become available, pending the results of further preclinical studies and clinical trials. The most effective and tolerable compounds will expand the available therapeutics for the treatment of viral diseases," explains Aleksandr Ianevski, the first author of the study and a Ph.D. student at NTNU. n Antiviral Therapies Treat Multiple Viruses

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