Regulatory

Among the hottest topics in biosimilar development is the future of clinical trials, and that fact was evident during the opening session of the fifth DIA Biosimilars Conference, held October 22 to 23 in London, United Kingdom. During the presentation, a review of the biosimilar regulatory framework, 4 experts explained the ways in which the landscape for clinical trials is evolving for biosimilars.

Genentech announced this week that the FDA has approved an update to its reference rituximab’s (Rituxan) label.

Mylan and Biocon’s biosimilar trastuzumab, which will be sold as Ogivri and which references Herceptin, today received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

The Center for Biosimilars® recaps the top news for the week of October 15, 2018.

The Center for Biosimilars® recaps the top news for the week of October 8, 2018.

Kashyap Patel, MD, a medical oncologist at Carolina Blood and Cancer Care, said after the FDA’s Oncologic Drug Advisory Committee (ODAC) hearing on CT-P10 that "Clearly, the mood has changed to be a lot more favorable for the biosimilars.”

In June, the American Medical Association's (AMA) president Barbara L. McAneny, MD, outlined the group’s concerns during a hearing held by the California Department of Insurance stating that “The AMA has come to the conclusion that this merger would likely substantially lessen competition in many healthcare markets, to the detriment of patients,” and therefore should be blocked.

In a vote on whether the totality of the evidence supported the licensure of CT-P10 as a biosimilar to Rituxan, all 16 Oncologic Drug Advisory Committee (ODAC) members voted yes, for reasons some enumerated as “overwhelming biosimilarity and clinical trial evidence” that “really sealed the deal.”

The Association of European Cancer Leagues, a nonprofit, pan-European organization of national and regional cancer societies, has issued a new white paper that calls for greater biosimilar use as a means to reduce costs and increase patient access to cancer treatment.

The FDA's Oncologic Drugs Advisory Committee (ODAC) briefing documents state that the totality of the evidence suggests that the proposed biosimilar is highly similar to its US-licensed reference, despite minor differences in clinically inactive compounds.

The Center for Biosimilars® recaps the top news for the week of October 1, 2018.

The United Kingdom has opened a consultation on provisions that it hopes will ensure the supply of medicines in the event that no agreement can be made between the United Kingdom and the European Union before the Brexit deadline.

Tanvex BioPharma, a Taiwan-based biopharmaceutical company, announced this week the submission of its Biologics License Application (BLA) to the FDA for TX-01, a proposed filgrastim biosimilar referencing Neupogen.

The FDA this week announced revised draft guidance that it says will help ensure that citizen petitions cannot be used by brand-name drug makers to delay the market entry of generics or biosimilars of branded products.

The Association for Accessible Medicines (AAM) and the Biosimilars Council (a division of AAM) have submitted comments to the FDA in reference to its Biosimilar Action Plan.

This guidance document comes after AllTrials, an international initiative, launched a tracking tool in February 2018 that publicly discloses which research entities have not reported data from clinical trials.

Dong-A ST, a biosimilar developer based in the Republic of Korea, has, together with Sanwa Kagaku Kenkyusho, filed for Japanese regulatory approval of DA-3880, a darbepoetin alfa biosimilar referencing Aranesp.

From the FDA’s hearing on the Biosimilar Action Plan to European approval of the first pegfilgrastim biosimilars, September was a banner month in biosimilar regulation.

The Initiative for Medicines, Access, and Knowledge (I-MAK) report notes that 89% of these applications were filed in the United States after Humira was already on the market, and 49% were filed after the first patent expired in 2014.

According to an unofficial estimate by the Congressional Budget Office, the Biosimilars Competition Act of 2018 will save about $100 million from 2019 to 2028.

The Center for Biosimilars® recaps the top news for the week of September 24, 2018.

Recent weeks have seen heightened debate over the need for phase 3 confirmatory trials for biosimilars, with some stakeholders calling these trials unnecessary and others going so far as to call them unethical. During the SMi 9th annual conference on Biosimilars and Biobetters, held September 26-27 in London, United Kingdom, Uwe Gudat, MD, who serves as head of clinical safety and pharmacovigilance at Fresenius Kabi, weighed in. “The subject I raise is rather provocative,” he acknowledged.

Samsung Bioepis announced that the FDA has accepted a Biologics License application (BLA) for its adalimumab biosimilar, SB5, referencing Humira.

While every biologics manufacturer has its own standards against which it measures a product’s consistency over time, there is an increasing need for harmonization of these in-house standards with a public standard that can serve as a benchmark for the reference product and all biosimilars. This, explained Meenu Wadhwa, PhD, is where World Health Organization (WHO) international standards come in.

Advocates took to Capitol Hill last week to brief lawmakers and their staff about the implications the recent CMS policy change may have on patient access to treatments.

The European Union (EU) today authorized its second pegfilgrastim biosimilar, referenced on Neulasta. The product, to be sold as Pelgraz, is indicated to reduce the duration of neutropenia, as well as the incidence of febrile neutropenia for adult patients undergoing cytotoxic chemotherapy.

The product is the first pegfilgrastim biosimilar to be authorized by the European Commission and the first Coherus product to be cleared by a regulatory authority.

In its report, the Congressional Budget Office (CBO) notes that it “expects that the bill’s provisions would allow generic drugs (including biosimilar versions of biologics) to enter the market earlier, on average, than they would under current law.” Additionally, CBO said that enacting the legislation would reduce federal spending on prescription drugs.

Today, Sandoz, Cinfa Biotech, and Mylan all revealed that they have received positive recommendations from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for proposed pegfilgrastim biosimilars referencing Neulasta.

Brazil benefits from a program, known as the Partnership for Productive Development, that brings together government and the private sector to develop strategic products of interest to the Brazilian health system—including biosimilars of high-cost biologics that account for approximately half of annual drug spending.