Regulatory

Biosimilars have improved access to health care in India, but many effective new drugs are high priced and patented, and authors of a new study recommend interventions to make these available, too.

Despite there being concerns over the safety of nonmedical switching between a reference product and a biosimilar, there is a growing body of evidence supporting the safety of switching, according to an executive of Sandoz, which produces biosimilars.

Shanghai Henlius Biotech has been given the green light to market its trastuzumab biosimilar (Zercepac, HLX02) in the European Union. Accord Healthcare will handle the distribution.

Although more advanced than in the United States, biosimilars markets in Europe may discourage competition over the long term, said officials from Medicines for Europe.

Additional indications for Remsima SC, an infliximab biosimilar, are approved by the European Commission (EC).

The Center for Biosimilars® (CfB) spoke with Adrian van den Hoven, director general of Medicines for Europe, and Diogo Piedade, market access manager for Medicines for Europe, about their scorecard report for biosimilar access in European markets.

We sat down with Anurag Rathore, PhD, lead author of the study and coordinator of the Center of Excellence for Biopharmaceutical Technology in Delhi, India, to discuss the findings from this study and how biosimilar corporations can learn from them.

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.