Business

As biosimilar competition nears for Roche and its subsidiary, Genentech, a new WARN notice in the state of California disclosed that Genentech is set to lay off 223 employees from a local plant beginning August 31, 2018.

Eli Lilly says that it will not comply with a 2017 California law on drug pricing, and now the state senator who sponsored the bill is hitting back against the drug manufacturer, calling the company’s activities to promote its diabetes programs “disingenuous and offensive.”

In the FDA’s Biosimilar Action Plan, the agency indicated that it seeks to partner more closely with the Federal Trade Commission (FTC) to help remove barriers to competition that are not directly within the FDA’s control. However, in recent comments to HHS, the FTC has called on the FDA to use its own authority to foster biosimilar competition.

CVS Caremark will allow clients to exclude any drug launched at a price greater than $100,000 per quality-adjusted life year from their plans.

Now that multiple biosimilars of adalimumab (Humira) are approved, though none have launched in the United States or European Union, attention is turning toward the next wave of biosimilar candidates.

This month, AbbVie filed suit against biosimilar developer Sandoz over its proposed adalimumab (Humira) biosimilar. The suit was filed in the District of New Jersey and alleges infringement under the Biologics Price Competition and Innovation Act.

The district court for the Eastern District of Pennsylvania has denied Johnson & Johnson’s motion to dismiss an antitrust civil action brought by Pfizer over infliximab.

This week, Samsung, the parent company of Samsung BioLogics and biosimilar development company Samsung Bioepis, announced plans to invest $22 billion across business lines, including biopharmaceuticals.

Celltrion has announced that it is ready to begin a phase 3 trial of its proposed bevacizumab biosimilar, CT-P16. The multicenter study will begin in Portugal and will eventually include approximately 150 sites in 20 nations in Europe, Asia, and South America.

The Center for Biosimilars® recaps the top 5 articles for the week of August 6, 2018.

Celltrion’s Korean plant has received its second Form 483 from the FDA in less than a year, only months after having received a warning letter for the same facility.

Teva announced this week that the FDA has approved its tbo-filgrastim (Granix), a follow-on product referencing Neupogen, to reduce the duration of severe neutropenia in patients as young as 1 month old who have nonmyeloid malignancies and are receiving myelosuppressive chemotherapy.

Express Scripts framed its formulary as a response to pharma: “Despite promises to limit price increases, drug makers are trying to game the market by delaying generic competition, blocking access to safe and effective biosimilars, and coyly deferring—not cancelling—list price increases,” it said.

The government has launched a consultation that outlines the proposed changes to its price controls, which require brand-name drug makers to pay the government 7.8% of their sales of products to the National Health Service.

Korean drug maker Celltrion has announced that it ready to begin phase 1 and phase 3 clinical trials for CT-P17, a proposed adalimumab biosimilar referencing AbbVie’s Humira, which is used to treat a variety inflammatory diseases. The trials will be conducted simultaneously at 75 sites in 8 nations in the European region including the United Kingdom, and the company indicates that the trials will be completed by 2020.

The Initiative for Medicines, Access, and Knowledge (I-MAK), a public interest team of attorneys and scientists who seek to ensure that patents do not obstruct patient access to affordable medicines, has issued a new report that details the number of patents drug makers have attempted to secure for the highest-grossing drugs in the United States.

Stada, a biopharmaceutical company based in Germany, recently announced that it is increasing its presence in the biosimilar sphere by becoming the majority shareholder in Bioceuticals, a venture capital-funded organization created by Stada to carry out its biosimilar programs.

Australia’s Therapeutic Goods Administration has approved Celltrion’s Herzuma—the country’s first biosimilar trastuzumab—referencing Herceptin.

China-based Clover Biopharmaceuticals recently announced that the first patient was dosed in a phase 1 trial of SCB-808, a potential etanercept (Enbrel) biosimilar.

This week, the European Medicines Agency (EMA) announced that it will scale back and even fully suspend a number of its activities in order to cope with Brexit-related pressures, and as the possibility grows stronger that the United Kingdom and the European Union may not reach a trade agreement, some drug makers have begun to stockpile key medicines to help guard against a supply disruption.

Vizient, a healthcare performance improvement company, recently released its Drug Price Forecast Highlights biannual report that provides an estimate of the change in the cost of medicines for 2019.

The Association for Accessible Medicines (AAM) has released the 10th edition of its annual Generic Drug Access and Savings Report that provides an outline of the savings generated by generics and biosimilars in the past year.

Bio-Thera Solutions, a global biotechnology company based in Guangzhou, China, recently announced that it has initiated a phase 1 clinical trial for BAT1806, a proposed tocilizumab (Actemra) biosimilar.

Pfizer announced today that the European Commission (EC) has approved its trastuzumab biosimilar, Trazimera, referencing Herceptin, for marketing. The approval makes Trazimera the fourth trastuzumab biosimilar (following Kanjinti, Ontruzant, and Herzuma) to be approved by the EC, and the first approval of an anticancer biosimilar for Pfizer.

Drug maker Mylan, which in June received FDA approval for its biosimilar pegfilgrastim, Fulphila, confirmed in an email to The Center for Biosimilars® that it has launched the biosimilar in the United States marketplace. Fulphila is the fourth biosimilar—and the first pegfilgrastim biosimilar—to become available to US patients.

Mylan, together with partner Fujifilm Kyowa Kirin Biologics, has gained a positive opinion on its adalimumab biosimilar, FKB327, from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). The advisory body recommended the biosimilar for all indications of the reference Humira. If the product is granted a marketing authorization by the European Commission, Mylan plans to sell the drug under the brand name Hulio.

Drug maker Coherus announced today that it has received a positive opinion on its pegfilgrastim biosimilar, CHS-1701, from the European Medicines Agency’s Committee for Human Use (CHMP). Coherus plans to sell the drug under the name Udenyca. Separately, Accord Healthcare received a positive opinion for its own pegfilgrastim biosimilar, which it plans to market as Pelgraz.

Biosimilar developer Sandoz announced today that the European Commission has granted a marketing authorization for Hyrimoz, an adalimumab biosimilar, for all of the indications for which the reference adalimumab, Humira, is approved.

The Center for Biosimilars® recaps the top 5 articles for the week of July 23, 2018.

A new trastuzumab (Herceptin) biosimilar has launched in India. Dr Reddy’s Laboratories, the developer of the biosimilar, indicated that the drug will be sold under the name Hervycta, and that it has been approved in India to treat HER2-postive early breast cancer, metastatic breast cancer, and metastatic gastric cancer.