Regulatory

This week, a research letter published in JAMA gives some insight into how biosimilars of long-acting insulins could impact the cost of insulin therapy for patients with diabetes.

Spectrum Pharmaceuticals has withdrawn its Biologics License Application (BLA) for eflapegrastim, a granulocyte colony-stimulating factor (G-CSF) therapy that the company had hoped to sell under the brand name Rolontis.

Lupin and YL Biologics announced today that they have received approval to manufacture and sell YLB113, a biosimilar etanercept product, in Japan. The product will be Lupin’s first biosimilar to come to the Japanese market.

The FDA's updated guidance on the naming of biologics, biosimilars, and interchangeable products has caused deep concern among some proponents of biosimilars, and one stakeholder has now filed a citizen petition with the FDA in which he asks that the guidance be withdrawn.

Last year, biosimilar developer Pfizer submitted a citizen petition to the FDA in which it called on the agency to issue guidance clarifying how drug sponsors can communicate about biosimilars. After the petition was filed, The Center for Biosimilars® invited an expert group of stakeholders to discuss misinformation about biosimilars as well as what steps are necessary to root out and address the misinformation.

The Center for Biosimilars® recaps the top news for the week of March 18, 2019.

During the first day of the BioTech Pharma third annual Biosimilars and Biologics Summit, held March 21 to 22 in Porto, Portugal, Barbara Valenta-Singer, MD, chief medical officer of biosimilars at Fresenius-Kabi SwissBioSim, gave an expert perspective on the past 10-plus years of experience with biosimilars in the European and US contexts.

The European Commission has approved Roche’s innovator rituximab, sold in Europe as MabThera, for the treatment of pemphigus vulgaris (PV), a rare autoimmune disorder. The approval marks the first biologic approval for PV in the European Union, and the first major new therapeutic option in 60 years.

The Biosimilars Forum and Medicines for Europe today released a joint white paper that discusses how Europe has successfully sustained its multisource biosimilars market for the past 10 years. The forum also suggests that the United States make structural changes in order to achieve similar success.

The Center for Biosimilars® recaps the top news for the week of March 11, 2019.

The United Kingdom’s Competition and Markets Authority has closed an investigation into an alleged anticompetitive discount scheme related to brand-name infliximab, Remicade.

The new acting chief of the FDA, Ned Sharpless, MD, has a track record with the biotechnology industry and a friendly relationship with the man he is replacing, Scott Gottlieb, MD.

On Wednesday, the House Committee on Energy and Commerce held a Health Subcommittee legislative hearing on lowering the cost of prescription drugs. The 7 bills that were the subject of the hearing include several items of legislation that have long waited for congressional action as well as new proposals to address the need for increased competition.

The FDA has issued a new Form 483 to Biocon over the Bangalore facility where it produces its biosimilars. The document makes 2 inspection observations that stem from an inspection carried out in February 2019.

The Trump administration has released its proposed budget for the fiscal year 2020, and contained within it are a variety of proposals that impact biosimilars.

The FDA has approved Pfizer’s trastuzumab-qyyp (Trazimera), a biosimilar referencing Herceptin.

After the FDA published updated draft guidance on the naming of biologics, biosimilars, and interchangeable biosimilars, biosimilar developers were quick to voice their concerns. According to industry, the FDA’s decision to require 4-letter, nonmeaningful suffixes for biosimilars, interchangeable biosimilars, and new biologics—but not already approved biologics—could seriously hinder biosimilar uptake.

The Center for Biosimilars® recaps the top news for the week of March 4, 2019.

The FDA has issued an updated draft guidance on the naming of biologics, biosimilars, and interchangeable biosimilars.

A few weeks after the United States Supreme Court rebuffed Maryland in its attempt to regulate drug prices, legislative committees are meeting Wednesday on a drug price transparency bill, as well as a bill to create a commission to review prices and set ceilings on insurers, pharmacies and hospitals.

News that FDA Commissioner Scott Gottlieb, MD, will step down from his position in 1 month’s time took stakeholders by surprise on Tuesday and raises questions about how the agency will approach biosimilars when it comes under new leadership. While Gottlieb’s departure has garnered the most attention, it is not the only recent FDA shake-up that could have an impact on the agency’s approach to biosimilars; Leah Christl, PhD, previously the director of the Therapeutic Biologics and Biosimilars Staff in the Office of New Drugs, left the FDA in February 2019.

A Kaiser Health News (KHN) analysis found that about one-half of the patient advocacy groups appearing in national ads opposing a Trump administration proposal to change how Medicare Part D covers drugs in protected classes have received pharmaceutical industry funding.

The FDA has approved a subcutaneously administered version of the brand-name trastuzumab, Herceptin. The new formulation, trastuzumab and hyaluronidase-oysk, is a combination of the anticancer agent trastuzumab and an endoglycosidase that allows for the administration of higher volumes and enhanced absorption, and it has been approved under the name Herceptin Hylecta.

Eli Lilly and Company said Monday it is introducing a lower-priced authorized generic of its insulin lispro injection (Humalog) in the United States. The generic will have a list price 50% lower than the current Humalog list price.

As the United Kingdom continues to move toward its exit from the European Union without an agreed-upon deal, the UK National Institute for Biological Standards and Control has issued new guidance for manufacturers of biologics in preparation for a no-deal Brexit, and the European Medicines Agency issued a new communication to drug makers seeking Brexit-related Type 1 variations to their marketing authorizations.

Regulators in China have approved the country’s first ever biosimilar, a rituximab product referencing Rituxan. The product, HLX01, was developed by Henlius and will be primarily used in the treatment of non-Hodgkin lymphoma. Regulatory requirements that were applied in the analysis of the drug, say investigators who took part in its development, will set a precedent for analytical similarity assessments of biosimilars in China going forward.

The Center for Biosimilars® recaps the top news for the week of February 18, 2019.

Despite the fact that the investigation confirmed many of the allegations against Janssen, the bureau concluded that, "at this time, there is insufficient evidence" that Janssen's conduct prevented competition.

The World Health Organization has long recognized the need for a global harmonization of standards for biologics worldwide. In response, the United Kingdom's National Institute for Biological Standards and Control has developed the first international standard for infliximab.

AbbVie has announced that the FDA has accepted for priority review its New Drug Application for upadacitinib for the treatment of rheumatoid arthritis (RA). Upadacitinib is a proposed once-daily, small-molecule, oral Janus kinase inhibitor that, if approved, could be an alternative to therapy with such injectable biologics as AbbVie’s flagship RA treatment, adalimumab (Humira), which will face biosimilar competition in the United States by 2023.