Samantha DiGrande

This week, Japan-based Fuji Pharma announced that it has acquired a 4.2% stake in Alvotech, a biopharmaceutical company focused on the manufacturing of biosimilars, for roughly $50 million.

Researchers presented results from a simulation analysis that looked to identify the potential reduction in Medicare beneficiaries’ out-of-pocket costs through the use of biosimilar filgrastim-sndz (Zarxio, Sandoz) over the reference filgrastim at the 2018 San Antonio Breast Cancer Symposium held December 4-8, 2018, in San Antonio, Texas.

Under terms of the agreement, Cipla will have exclusive rights to distribute and market Prestige’s trastuzumab biosimilar (HD201) in selected emerging markets.

Senator Elizabeth Warren, D-Massachusetts, has introduced a bill in the Senate that would create an Office of Drug Manufacturing within HHS. Simultaneously, Representative Jan Schakowsky, D-Illinois, introduced an identical bill in the House of Representatives.

Last week, Insurer Cigna and pharmacy benefit manager (PBM) Express Scripts overcame 2 hurdles to completing their $67 billion merger as New York and California insurance regulators signed off on the deal.

Johnson and Johnson (J&J) recently filed a motion to dismiss in the antitrust claim brought against the company by Walgreen and Kroger in regard to sales of J&J’s reference infliximab product, Remicade. In early December, the District Court for the Eastern District of Pennsylvania denied the motion.

Yesterday, 4 senators introduced a bill on the Senate floor that would allow HHS to block drug price increases that it deems as “excessive.”

Pfizer disclosed that it would increase the price of 41 drugs; 37 drugs will see price increases of 5%, 1 drug by 9%, and 3 drugs by 3% on January 15, 2019. The announcement was met with pushback from politicians who have been vocal about drug pricing concerns.

Recently, plaintiff Genentech and defendant Pfizer filed a collective stipulation and proposed order of dismissal of a patent infringement lawsuit over Genentech’s reference trastuzumab product, Herceptin.

Yesterday, 339 patient, provider, and caregiver groups, on behalf of the Part B Access for Seniors and Physicians Coalition, sent a letter to Congress encouraging lawmakers to block the implementation of the International Pricing Index (IPI) model that was announced last month.

In October, the FDA granted approval for a pre-filled syringe formulation of the reference product. Additionally, Novartis is looking to expand omalizumab’s indications, as it recently earned FDA’s breakthrough therapy designation in August 2018 as a treatment for food allergies.

The complaint includes a screenshot of Xanthe Lam’s Genentech-issued computer, which shows a folder titled “JHL” that contained subfolders, 4 of which were named for Genentech medicines for which JHL was in the process of developing a biosimilar.

In the United States, Amgen has 57 patents on Enbrel, whereas in Europe it has 20, and in Japan it has 18.

Last month, the European Parliament’s Health Committee introduced amendments to Supplementary Protection Certificate (SPC) manufacturing waivers. On December 4, 2018, the committee voted in favor of the amendments.

There are several options for the prophylaxis of febrile neutropenia (FN), including pegfilgrastim delivered in an on-body injector (OBI), a single injection of pegfilgrastim, and daily injections with reference filgrastim or Sandoz’ biosimilar filgrastim.

The study’s authors concluded that, at the median follow-up of 23 months, the data demonstrated comparable progression-free survival, sustained response, and overall survival between both the biosimilar and the reference product.

In 2016, the Saskatchewan Cancer Agency switched from the brand-name filgrastim, Neupogen, to a biosimilar, Apotex’s Grastofil, for stem cell mobilization prior to autologous stem cell transplants. In a study presented at the American Society of Hematology’s Annual Meeting, researchers sought to determine the safety and efficacy of using a biosimilar for this setting.

The researchers concluded that the efficacy, safety, immunogenicity, pharmacokinetics, and pharmacodynamics of PF-05280586 and the reference were similar at the conclusion of the study at week 26.

Earlier this week, Daiichi Sankyo announced that it has launched its biosimilar trastuzumab, trastuzumab BS, referencing Herceptin, in Japan.

Earlier this week, Bioprocess International reported that Boehringer Ingelheim (BI) had decided to focus on launching its biosimilar products solely in the US market, and would forego launches in the European Union. The Center for Biosimilars® was able to independently confirm this report in an email with a representative from BI.

This week, the European Parliament’s Health Committee introduced amendments to Supplementary Protection Certificate (SPC) manufacturing waivers.

The European Commission, in conjunction with the Organization for Economic Co-operation and Development, has released its Health at a Glance: Europe 2018 report which highlights the need for and value of generic and biosimilar products.

Last week, Biosimilars Canada, a trade organization representing Canada’s biosimilar developers including Sandoz, Mylan, and Fresenius Kabi, among others, announced that it had chosen Innomar Strategies to be the preferred provider for the Biosimilars Canada Patient Support Program platform.

Biosimilar developer Alvotech and Fuji Pharma have entered into a partnership agreement for the commercialization of Alvotech’s entire pipeline of biosimilars in Japan, the companies announced this week.

Mylan and Biocon jointly announced earlier this month that their biosimilar insulin glargine, sold as Semglee and referencing Lantus, has launched in the United Kingdom.

The FDA recently announced that it approved a record-breaking number of generic drugs in October 2018.

This month, Novartis submitted a letter to the FDA in support of a citizen petition that Pfizer filed in August.

Sandoz, a subsidiary division of Novartis, has launched its infliximab biosimilar, Zessly, in Germany. The launch brings the number of infliximab biosimilars available in Germany to 3.

A key factor in overcoming barriers to United States market entry is sharing the positive experiences of both healthcare professionals and patients, explained HoUng Kim, Head of Strategy and Operations Division, Celltrion Healthcare during a presentation at SMi Biosimilars USA Conference in Iselin, NJ, that took place November 14-15, 2018.

Being able to switch from a reference product to a biosimilar is important for 3 reasons, explained Hillel Cohen, PhD, executive director of scientific affairs at Sandoz, during his presentation at SMi Biosimilars USA Conference in Iselin, New Jersey, held November 14-15, 2018.