Business

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.

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

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.

The Center for Biosimilars® recaps the top news for the week of September 17, 2018.

The partnership says that it will launch the drug in the European Union on or after October 16, 2018.

The State of California has filed suit against drug maker AbbVie, alleging that the company provided kickbacks to healthcare providers throughout the state to encourage them to prescribe its brand-name adalimumab, Humira, and used a network of registered nurses to mislead patients about the risks associated with the drug.

The Center for Biosimilars® recaps the top news for the week of September 10, 2018.

Only 38% of Americans say that they are either very confident or somewhat confident that the administration’s plan will result in paying less for their prescription drugs.

Korean drug maker Celltrion says that the FDA’s Oncologic Drugs Advisory Committee (ODAC) will convene to discuss the Biologics License Application (BLA) for CT-P10, a proposed biosimilar rituximab, on October 10, 2018. CT-P10 is already authorized in the European Union, where it was approved under the trade names Rituzena, Ritemvia, Truxima, and Blitzima.

The National Institute for Health Research's Clinical Research Network maintains an active list of more than 800 clinicians—practicing in oncology, gastroenterology, endocrinology, and dermatology—who are interested in delivering trials of biosimilar medicines.

Xbrane’s lead biosimilar candidate is a ranibizumab product (referencing Lucentis), developed in collaboration with Stata, that is moving into a pivotal clinical trial. The study will enroll patients with wet age-related macular degeneration across 16 countries.

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.

The Center for Biosimilars® recaps the top news for the week of September 3, 2018.

Two research letters, published concurrently in the Journal of the American Medical Association, focused on biosimilars and their role in the Medicare population.

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.”

Janssen’s drug, sold in New Zealand as Eprex (and in the United States as Epogen) would lose funding after a transition period beginning in February 2019. After the close of the transition, only Novartis’ approved biosimilar, sold as Binocrit, would be eligible for funding in community and hospital settings.

Celltrion announced last week that it has completed its phase 3 clinical trial for subcutaneous biosimilar infliximab (CT-P13, sold in the United States as Inflectra and in other territories as Remsima), and that it will now prepare a marketing authorization application for submission to the European Medicines Agency.

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.

The Center for Biosimilars® recaps the top news for the week of August 27, 2018.

Reimbursement of a second biosimilar infliximab could provide welcome savings in a health system struggling with high drug costs.

Sandoz, with its filgrastim biosimilar (Zarxio) having been the first biosimilar to gain FDA approval and to launch in the US market, has had extensive experience in the biosimilars space. Carlos Sattler, MD, head of clinical development and medical affairs at Sandoz, recently spoke with The Center for Biosimilars® about both the biosimilar development process and the regulatory landscape that lies ahead.

The government is asking pharmaceutical companies to stockpile an additional 6-week supply of medicine, on top of their usual stock levels, in case normal supply routes through the European Union are disrupted.

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.

Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) has recommended that 2 adalimumab biosimilars be treated as equivalent to the reference adalimumab, Humira, and be subject to substitution at the pharmacy level.

The Center for Biosimilars® recaps the top news for the week of August 20, 2018.

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.