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Drug maker Biocon has received a Form 483 from the FDA after an inspection of its manufacturing facility in Malaysia.

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of February 19, 2018.

The international initiative AllTrials has launched a new online tracking tool that publicly discloses which research entities have not reported data from clinical trials.

Pharmacy benefit manager Express Scripts and Walgreens Boots Alliance, Inc, have announced that they will expand their group purchasing efforts to include specialty drugs, including biologics and biosimilars.

Biocad, a Russia-based drug manufacturer, received approval for an infliximab biosimilar (referencing Remicade) from Russia’s Federal Drug Control Service last month. The company anticipates expanding to other markets as soon as later this year, or early 2019.

A white paper released this month by the Association for Accessible Medicines (AAM) says that brand-name drugs are behind high prescription drug costs, and that those costs aren’t only hurting patients’ financial wellbeing, but also endangering their health.

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of February 12, 2018.

Ireland’s Minister for Health, Simon Harris, announced this week that Ireland is seeking to join Belgium, the Netherlands, Luxembourg, and Austria in their BeNeLuxA Initiative, a group that negotiates price deals on pharmaceuticals directly with manufacturers.

Yesterday, Eli Lilly announced that its anti–IL-17 monoclonal antibody ixekizumab (Taltz) met the primary and key secondary endpoints in the phase 3 COAST-V trial evaluating its safety and efficacy in ankylosing spondylitis.

Celltrion’s head of strategy and operations, Ho Ung Kim, told reporters this week that the intravenous Herzuma could be launched at as much as a 50% discount to a subcutaneously administered presentation of the reference Herceptin.

Roche has released positive phase 2 data for its proposed novel anti–vascular endothelial growth factor and anti–angiopoietin-2 bispecific antibody, RG7716.

Yesterday, President Trump released his budget proposal for the 2019 fiscal year. On the same day, the Proceedings of the National Academy of Sciences of the United States of America released a paper summarizing the NIH’s contribution of funding to new drugs approved from 2010 to 2016.

On Friday, the White House’s Council of Economic Advisors (CEA), an agency within the Executive Office of the President, released a white paper titled “Reforming Biopharmaceutical Pricing at Home and Abroad.”

“It is likely that the remediation by Celltrion of the issues addressed in the warning letter will result in a delayed approval of the biosimilar products by the FDA,” Teva told investors.

Novartis announced on Thursday that the FDA has approved a label update for secukinumab (Cosentyx) to include moderate to severe scalp psoriasis, a particularly challenging form of psoriasis to treat, and a condition that affects approximately half of patients with psoriasis.

According to the recently released Personalized Medicines Coalition 2017 Progress report, the FDA approved a record number of 16 new personalized medicines in 2017.

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of February 5, 2018.

The Federal Circuit on Monday affirmed a previous district court dismissal of drug maker AbbVie’s suit against MedImmune Limited over US Patent 6,248,516 (“the ’516 patent”).

YL Biologics, a partnership forged between Lupin Pharmaceuticals and Yoshindo Inc to develop and market biosimilar therapies, has announced the successful completion of a global, phase 3 clinical trial of its proposed etanercept biosimilar, YLB113.

The fourth-quarter and full-year 2017 earnings report from Amgen highlights the fact that biosimilars can be both a challenge and an opportunity for drug makers whose innovator products face biosimilar competition and who develop biosimilar products of their own.

Former Representative Henry Waxman told The Center for Biosimilars® in an email that the CREATES Act “…tackles one of the numerous problems driving high drug prices—drug manufacturers’ use of anti-competitive tactics to block access to generic drugs.

Biosimilars have begun to erode sales of Roche’s innovator rituximab (MabThera in Europe, Rituxan in the United States), according to the drug maker’s 2017 annual report.

A cross-sectional study published in the International Journal of Clinical Pharmacy in late 2017 found that the uptake of biosimilars in the United Kingdom has been highly variable and generally lower than expected.

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of January 29, 2018.

Biosimilars have reached a tipping point in the US market, according to a new drug pricing forecast from consulting company Vizient.

The FDA has issued a warning letter to Celltrion, maker of the infliximab biosimilar Inflectra. The company announced today that, on January 30, the company received a letter from the agency that “raises issues related to certain manufacturing process[es]” at its Incheon, Republic of Korea facility.

Higher levels of cancer-related financial toxicity are associated with decreased quality of life, poorer treatment adherence, and poorer survival for adult patients with cancer.

Trump said of Azar, who was confirmed by a vote of 55 to 43 on January 24 to replace Tom Price, MD, as Secretary of HHS, “He’s going to get those prescription drug prices way down…it’s going to come rocketing down.”

Jeff Bezos, Amazon’s founder and CEO, said that reducing healthcare’s burden on the economy while improving outcomes for employees and their families would be worth the effort, and the 3 companies had the talented experts with fresh approaches and a long-term orientation that will be key to success.

Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen, is expected to post its first profits in 2018, according to estimates made by a Republic of a Korea-based securities firm.