Samantha DiGrande

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

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.”

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.

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 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.

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 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.

The poll found that 82% of Republicans, 92% of Democrats, and 91% of Independents polled supported legislation to limit nonmedical switching.

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.

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

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 National Health Service’s (NHS) Specialist Pharmacy Service released resources for clinicians to use with patients in the discussions around switching from the reference Humira to a biosimilar.

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.

Senator Dick Durbin, D-Illinois, a co-sponsor of the amendment, placed blame on pharmaceutical companies for using their influence to block the measure.

This week, Boehringer Ingelheim announced results from a 16-week phase 3 study that confirmed biosimilar adalimumab-adbm (to be sold as Cyltezo) was clinically equivalent to the reference product, Humira.

At a panel at the GRx+Biosims 2018, Molly Burich, MS, director of public policy for biosimilars and reimbursement at Boehringer Ingelheim, and Melissa Andel, MPP, vice president of health policy at Applied Policy, discussed the impact that US policy developments are having and will continue to have on the biosimilars market.

Alex Brill, CEO of Matrix Global Advisors, gave a presentation during the GRx+Biosims 2018 conference in Baltimore, Maryland that discussed the barriers to increased uptake of biosimilars in the United States, and how to address those issues.

In a session held at the GRx+Biosims 2018 conference in Baltimore, Maryland, Gillian Woollett, MD, DPhil, senior vice president of Avalere Health, and Michelle Lee-Bourner, head of regulatory affairs for biologics and respiratory products at Mylan, discussed experience with and expectations for biosimilar regulation.

Contrary to experience in the United States thus far, Europe has also seen what Marc-Alexander Mahl, MD, describes as “widespread support for switching biosimilars medicines under the supervision of a healthcare provider.” In fact, regulatory bodies in the EU have spoken out stating that “In our opinion, switching patients from the originator to a biosimilar medicine or vice versa can be considered safe.”

While the “FDA deservers tremendous credit to enhance and expedite [biosimilars]… there is also a reluctance or hesitation to provide a full account that while the rate of approvals has picked up, the amount of biosimilars on the market [remains low]. Approval is not a synonym for competition," said Chester Davis of the Association for Accessible Medicines.

Though biosimilars have the potential to provide a less costly option for patients, the products have not seen the uptake in the marketplace that the FDA had expected. This apprehension was reiterated in FDA Commissioner Scott Gottlieb’s comments at the meeting: “I’m not satisfied with the current state of the biologics market and biosimilars in particular.”

The Trump administration this week announced a preliminary trade deal between the United States and Mexico. Under the agreement, which looks to update the North American Free Trade Agreement, brand name drug makers will receive 10 years of exclusivity for biologics in addition to more products qualifying for this protection.

In regard to the naming guidance for biosimilars that states that each product must be given a random 4-letter suffix that is devoid of meaning, the organization encourages the FDA to reconsider.

It has now been more than 100 days since the Trump administration released the American Patients First blueprint, an effort to lower ever-increasing drug prices in the United States.

The FDA recently sent a warning letter to Kyowa Hakko Bio, the parent company of biosimilar developer Kyowa Kirin Biologics, in reference to an inspection of manufacturing plant, Hofu-shi, in Yamaguchi, Japan.

Bio-Thera Solutions, a Chinese-based biotechnology company, says that the China National Drug Administration has accepted its Biologics License Application for a potential adalimumab biosimilar, BAT1406. This is the first proposed adalimumab biosimilar to be accepted for review in China.