Business

According to the Congressional Budget Office (CBO), enacting the bill would increase direct spending by about $18.7 billion and increase direct revenues by $26.2 billion, resulting in a net decrease in the deficit of $7.6 billion by 2029.

Republic of Korea–based drug maker Celltrion announced this week that it is launching its first clinical trial of CT-P39, a proposed biosimilar omalizumab referencing Xolair. The company says that it plans to enter phase 3 trials in the first half of 2020 and has plans to commercialize the biosimilar by 2022.

Six months after launching its biosimilar pegfilgrastim, Udenyca, Coherus BioSciences announced that it has produced more that 400,000 prefilled syringes of its product.

This week, Mylan launched its biosimilar adalimumab, Hulio, in Spain. The biosimilar, referencing Humira, was developed by Mylan’s partner, Fujifilm Kyowa Kirin Biologics, and received European authorization in September 2018.

Singapore-based Prestige BioPharma announced this week that its HD204, a proposed biosimilar bevacizumab product referencing Avastin, met its primary end point in a phase 1 study evaluating the pharmacokinetics (PK), safety, and immunogenicity of the biosimilar in comparison to its reference.

The Center for Biosimilars® recaps the top stories for the week of July 8, 2019.

Samsung Bioepis, developer of the biosimilar trastuzumab, Ontruzant, and Genentech, maker of the reference trastuzumab, Herceptin, have asked a court to dismiss their patent litigation.

The Trump administration has withdrawn its proposal to block rebates and discounts given by drug makers to pharmacy benefit managers, Part D plans, and Medicaid managed care organizations.

The Center for Biosimilars® had a conversation with Alexandra D. Valenti, JD, of Goodwin’s Intellectual Property Litigation group, to help understand the recent discussions in the Senate Judiciary Committee about ongoing attempts at patent reform.

This week, a research letter appearing JAMA Internal Medicine reported on efforts to understand whether there exists an association between payments from drug makers and Medicare spending on adalimumab and certolizumab.

Biosimilar developer Biocon is facing yet another setback after the FDA issued another Form 483 for its insulin facility.

The United States District Court for the District of Columbia has vacated the Trump administration’s rule requiring the disclosure of wholesale acquisition costs for drugs in direct-to-consumer television advertising. The rule had been slated to take effect today, July 9.

Singapore-based Prestige BioPharma has entered into 2 new agreements related to its proposed biosimilar trastuzumab, HD201, which it hopes to sell under the brand name Tuznue.

Biosimilar developer Samsung Bioepis has gained an updated label for its biosimilar adalimumab, Imraldi, referencing Humira. The biosimilar is now approved for storage in nonrefrigerated conditions for up to 28 days. This update means that the biosimilar can now be stored for an additional 2 weeks at room temperature.

The multicenter, randomized, noninferiority, double-blind, controlled trial was conducted in China among 554 patients with active ankylosing spondylitis.

The European Commission approved ravulizumab (Ultomiris) for adults with paroxysmal nocturnal hemoglobinuria.

The Center for Biosimilars® recaps the 5 most-read stories of 2019 to date.

Two economists from the American Enterprise Institute (AEI) shot back at the idea that biosimilars are natural monopolies and should have their prices regulated by the government, as was proposed a little more than 2 months ago by critics who say that trying to wring lower drug prices through competition born from biosimilars is an experiment doomed to fail.

Amgen says it is withdrawing its European application for ABP 710, its biosimilar infliximab (referencing Remicade).

Mundipharma, a network of independent companies that operates in 120 countries worldwide and distributes a number of biosimilars in the European Union, has inked a deal with Budapest-based Egis Pharmaceuticals to distribute its biosimilar pegfilgrastim, Pelmeg, in 4 Eastern European markets: Hungary, Romania, Lithuania, and Latvia.

The FDA has approved Pfizer’s bevacizumab biosimilar, bevacizumab-bvzr, referencing Avastin.

The Center for Biosimilars® recaps the top stories for the week of June 24, 2019.

Alexion Pharmaceuticals’ brand-name eculizumab (Soliris) gained its fourth approval, this time for the treatment of neuromyelitis optica spectrum disorder (NMOSD).

Eli Lilly and Company, together with partner Innovent Biologics, announced today that China’s National Medical Products Administration will review its application for IBI301, a proposed rituximab biosimilar referencing MabThera and Rituxan.

The Biosimilars Council, a part of the Association for Accessible Medicines, has issued a new white paper in which it condemns abuses of the patent system that delay biosimilar competition. It also argues that legislative proposals to regulate settlements would “merely benefit companies investing in the creation of patent thickets.”

A panel at the ACI 10th Summit on Biosimilars focused on the recent FDA decision around the naming of biosimilar products and what that means for the industry, as well as related issues.

In this case, Pfizer hoped to launch its biosimilar bevacizumab in the UK market after the basic patent on the reference product, Genentech and Roche’s Avastin, expires in June 2020. However, the biosimilar maker has been hindered by what it has termed a patent thicket related to secondary patents.

The first set of presentations on day 2 of the ACI 10th Summit on Biosimilars on Tuesday in New York City reviewed the economics of biosimilar drugs and considerations for access, pricing, and reimbursement.

Drug maker AbbVie today announced that it has reached a $63 billion transaction agreement under which it will acquire Allergan.

Under which situations might the International Trade Commission (ITC) be the right choice for biosimilar patent disputes instead of federal district court? A panel discussed these questions at the ACI 10th Summit on Biosimilars on Monday in New York City.