Regulatory

President Trump signed 4 executive orders that would lower prices of prescriptions medications including insulin products and cancer medicines.

Biosimilar misinformation takes many forms, some of it institutionalized in the form of word usage and some of it deliberately disparaging, 2 executives of Sandoz and Boehringer Ingelheim contend.

The Center for Biosimilars® interviewed Anurag S. Rathore, PhD, whose team of investigators evaluated why applications for biosimilar approvals do not succeed. Large companies as well as small find the approval process challenging, but there is a learning curve that may be followed by more consistent approvals, he explains.

Ted Mathias and Stacie Ropka, PhD, intellectual property law partners with Axinn Veltrop and Harkrider LLP, met with The Center for Biosimilars® to discuss how insulins will be regulated under the Biologics Price Competition and Innovation Act (BPCIA) versus the Hatch-Waxman Act, as well as the new challenges follow-on manufacturers will face.

With insulin originator product patents expiring, drug companies are seeking to extend exclusivities via patents on injectors and other delivery products.

Investigators found that process complexities have created numerous difficulties for biosimilar developers in regulatory filings, but they anticipate that the success rate will improve with experience and improved guidance.

Now is the time for the FDA to lead again in revising the biosimilar development guidance by eliminating all animal toxicology studies, and replacing them with larger-species pharmacokinetic (PK) studies, allowing the conduct of human PK studies using novel clinical protocols to combine the PK/pharmacodynamic/immunogenicity testing in a single study, and, where possible, avoid these studies if an in-silico approach can provide the confidence of pharmacologic similarity.

The European Commission has granted market authorization to Sanofi for its insulin aspart biosimilar, making it the first approved biosimilar to NovoRapid for the region.

As the coronavirus disease 2019 pandemic continues to hinder the forward momentum for biosimilar approvals, FDA has shown that biosimilars are still a priority for the agency.

A new scorecard system developed by IQVIA rates the health and sustainability of biosimilars markets across Europe.

Based on clinical studies on dosing, efficacy, and pharmacokinetics, European authorities have recommended Celltrion's subcutaneous infliximab biosimilar (Remsima SC) for 5 new indications.

New prediction methodology for calculating biosimilar application fees will help the FDA cover its costs and respond quickly to changes in demand, officials said at a public meeting.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended Samsung Bioepis’ bevacizumab biosimilar for the treatment of multiple types of cancer.

HLX14, a denosumab biosimilar targeted for the treatment of postmenopausal osteoporosis in patients with a high risk of fractures, was approved by China’s National Medical Products Administration (NMPA).

Nick Mitrokostas, an intellectual property law attorney with Goodwin Proctor in Boston and editor in chief of Big Molecule Watch, discussed the impact on the US biosimilar market from the coronavirus disease 2019 (COVID-19) pandemic and the recent change to the Biologics Price Competition and Innovation Act (BPCIA).

Innovent Biologics said China’s National Medical Products Administration (NMPA) has approved its biosimilar bevacizumab, Byvasda, for use in patients with lung and colorectal cancers.

Christine Simmon, executive director of the Biosimilars Council and senior vice president of policy and strategic alliances at the Association for Accessible Medicines (AAM) discussed the new pathway for insulin biosimilars and the struggles between payers and providers over biosimilar choice.

Eli Lilly gets FDA approval for a new formulation of insulin lispro and offers it at the out-of-pocket cap of $35 for a monthly supply for patients with or without insurance.

The United States–Mexico–Canada Agreement came to a rocky impasse over drug exclusivity protections, and July 1 is the day this agreement takes effect.

Christine Simmon, executive director of the Biosimilars Council and senior vice president of policy and strategic alliances at the Association for Accessible Medicines (AAM) discusses potential legislation that the AAM is advocating for and how the upcoming election and Supreme Court decision will affect biosimilars.

Lannett’s insulin glargine biosimilar candidate will break new ground as it moves through the 351(k) review pathway, according to Ha Kung Wong, an intellectual property law attorney with Venable of New York.

Longtime generics maker Lannett, of Philadelphia, Pennsylvania, said an FDA meeting this week was positive for its pending insulin glargine biosimilar application.

The FDA has approved Pfizer’s pegfilgrastim biosimilar Nyvepria for use in lowering the incidence of infection as manifested by febrile neutropenia.

Although biosimilar uptake has been slow in the United States, the current administration has enacted several policies to help speed up the process, according to Michael Kolodziej, MD, who presented at the National Comprehensive Cancer Network (NCCN) 2020 Virtual Conference.

In July 2020 Canada will implement a series of reforms to help bring runaway drug prices under control, panelists said at Virtual ISPOR 2020, the annual meeting of the International Society for Pharmacoeconomics and Outcomes Research.

Real world evidence (RWE) was cited differently depending on a number of criteria, leaving the door open to future research on how RWE influences payer decision making for specialty drug plans, said presenting author, Ari Panzer, at the Virtual ISPOR 2020, the annual meeting of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR).

There’s not enough study of the effects of international reference pricing, but it is likely to stifle innovation and create access problems, according to an expert panel at Virtual ISPOR 2020, the annual meeting of the International Society for Pharmacoeconomics and Outcomes Research.

Although India is far ahead of other countries in terms of biosimilar approvals, its regulatory structure may hinder efforts for international sales.

India entered the biosimilar market early and has nearly 100 approved biosimilars, but experts say its regulatory system is not considered world-class, which may hinder international marketing of these products.