News

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.

On Thursday, biosimilar developer Sandoz announced that it had reached a global settlement of its patent disputes with AbbVie, maker of the reference Humira. The settlements will allow Sandoz to enter some European markets with its biosimilar adalimumab, Hyrimoz, as early as October 16, 2018.

Coherus BioSciences has launched a comprehensive website offering patients and providers support services for its biosimilars.

The paper reports findings from a study that used retrospective data from a single center in Poland from 2009 to 2014. Records from a total of 104 patients, each of whom received infliximab, etanercept, or adalimumab under the National Health Fund, were assessed.

As US healthcare increasingly moves toward value-based payment approaches, biosimilars, which reduce costs while maintaining treatment quality, can be an important driver of value. However, according to a white paper, a new framework for assessing the value of biosimilars is warranted.

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.

Mundipharma, a network of independent companies that operates in 120 countries worldwide, announced today that it has acquired biosimilar developer Cinfa Biotech. The deal will provide Mundipharma with access to B12019, a proposed biosimilar pegfilgrastim, referencing Neulasta, which received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in September 2018.

Earlier this month, the United States, Mexico, and Canada entered into the United States–Mexico–Canada Agreement, or USMCA, an updated version of the North American Free Trade Agreement. Since the details of the agreement were released, the pharmaceutical intellectual property portions of the deal have come under scrutiny.

Drug maker Alexion says that it is preparing for regulatory submissions in the United States, the European Union, and Japan for eculizumab (Soliris) for the treatment of anti-aquaporin-4 auto antibody-positive neuromyelitis optica spectrum disorder.

Fresenius Kabi announced today that its MSB11455, a proposed pegfilgrastim biosimilar referencing Neulasta, met its primary endpoints in 2 clinical studies that are intended to facilitate regulatory applications for the product in the United States and the European Union.

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.

According to the authors, the medical literature points to 3 key triggers of the nocebo effect, all of which offer possible solutions to overcoming the nocebo effect in switches to biosimilars.

Infliximab accounts for substantial drug spending in the United States, and dose rounding has become a common practice at many facilities as a way to avoid wasting vials that have only been partially used. However, many institutions do not have standardized approaches to rounding doses, and because infliximab requires a weight-based dose, rounding becomes even more complex.

Using electronic health records (EHRs) to create a learning healthcare system, say the authors, can enable researchers to generate new knowledge that will accrue benefits to future generations of patients.

The United States House of Representatives has passed the Patient Right to Know Drug Prices Act. The bill will now be sent to the President for his consideration, as the Senate already passed the bill earlier last month with an overwhelming majority of 92 to 2.

Merck’s infliximab biosimilar, sold as Renflexis and approved by the FDA in April of last year, was determined to be the lowest priced infliximab option available to the US Department of Veterans Affairs (VA), and was awarded a national contract. Subsequently, it has become the sole infliximab product available on the VA's National Formulary.

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.

“Comparison of estimated prices with recent government procurement prices suggests that robust competition in the human insulin and insulin analogue market would lead to sizeable savings in most countries and that current manufacturers could set significantly lower prices while still making a profit,” write the study’s authors.

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.

Swedish biotechnology company Xbrane Biopharma today announced that its ranibizumab biosimilar, referencing Lucentis, demonstrated an equivalent pharmacokinetic (PK) profile and equivalent tolerability to its reference in an in vivo study.

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.

The study randomized and dosed 589 patients with breast cancer with either the biosimilar, the EU-licenced reference pegfilgrastim, or the US-licensed reference pegfilgrastim.

Pfizer indicated that Nivestym will be priced at a wholesale acquisition cost (WAC) of $350.40 per 480-mcg prefilled syringe, a WAC that is 30.3% lower than that of the reference Neupogen.

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.