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The market for orphan drugs is set to grow over the next 4 years, a pharmaceutical report says.

This month saw steps forward for biosimilars in the rheumatology space, with product approvals in multiple markets and the publication of long-term data that support the use of biosimilar agents in treating inflammatory diseases.

Sandoz has announced that it has entered into a partnership with Taiwan-based biotechnology manufacturing and development company EirGenix, Inc, for a proposed trastuzumab biosimilar referencing Herceptin.

Amgen has now answered Coherus BioSciences’ complaint and denies that it has infringed on Coherus’ patents. Amgen also said that the patents are invalid for failure to comply with requirements of the law.

Last Friday, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Juta Pharma’s pegfilgrastim biosimilar, Grasustek.

The Center for Biosimilars® recaps the top news for the week of April 22, 2019.

The FDA has approved Samsung Bioepis’ etanercept biosimilar, SB4, as Eticovo (etanercept-ykro). A representative from Samsung Bioepis has confirmed approval of the product to The Center for Biosimilars® in an email. The biosimilar is already approved in a variety of other markets under the name Benepali.

Bio-Thera Solutions, a global biotechnology company based in Guangzhou, China, has reported the results of a clinical study of its proposed bevacizumab biosimilar, BAT1706, referencing Avastin.

During the first quarter of 2019, Samsung Bioepis’ biosimilars revenue increased to $175 million, up from $128 million in the first quarter of 2018. Those numbers, say Biogen, are driven by the launch of biosimilar adalimumab, Imraldi.

The approval comes as welcome news for AbbVie, which seeks to strengthen its immunology sales as it faces biosimilar competition for its flagship therapy, adalimumab (Humira).

Earlier this month, pharmacy benefit managers (PBMs) were called before the Senate Finance Committee to answer questions about how their businesses impact drug prices for Americans. While the executives deflected criticism and pointed to issues like legal challenges to biosimilars as playing a key role in keeping drug prices high, lawmakers and officials are taking steps to rein in PBMs.

Xbrane Biopharma, a Swedish biotechnology company, says it is starting its phase 3 trial of its ranibizumab biosimilar, referencing Lucentis, and also set sales targets for the treatment for patients with wet age-related macular degeneration.

In terms of attitudes toward the safety and efficacy of biosimilars, 84% of survey respondents agreed that switching to a biosimilar is safe and effective for patients whose conditions are treated by reference products, but only 54% agreed with the extrapolation of indications.

As biosimilars begin to gain ground in the country, Janssen, maker of a number of brand-name biologic products that face current or oncoming biosimilar competition, has launched a program—the Biologics Savings Partnership—that it says will offer patients brand-name biologics at prices similar to those of biosimilar options.

This week, the FDA granted priority review to Novartis’ innovator biologic, RTH258, brolucizumab. The vascular endothelial growth factor (VEGF) inhibitor is intended to treat wet age-related macular degeneration.

CMS’ final 2020 Payment Notice will allow insurers to stop counting the value of manufacturer drug coupons for branded drugs towards a beneficiary’s maximum out-of-pocket costs in order to promote the use of generic drugs.

The Center for Biosimilars® recaps the top news for the week of April 15, 2019.

Fuji Pharma will market Alvotech’s biosimilar ustekinumab in Japan, the companies announced this month.

This month, US magistrate judge Richard A. Lloret granted Boehringer Ingelheim (BI)’s motion to compel AbbVie to produce prelitigation disclosures and settlements concerning its brand-name adalimumab, Humira.

Yesterday, the European Parliament approved a proposal to allow waivers of supplementary protection certificates (SPCs) for EU generics and biosimilars by a vote of 572 to 36.

Last year, the average rise of per employee cost of specialty drugs was 12%, with oncology making up the largest category.

According to The International Generic and Biosimilar Medicines Association (IGBA)’s paper, despite global progress in strengthening the regulatory system for medicines, progress related to biologics and biosimilars has been less robust.

Magellan Rx Management, a pharmacy benefit manager (PBM), said today that its biosimilar management program has resulted in strong biosimilar uptake and significant drug cost savings for health plan organizations during its first year.

The Community Oncology Alliance (COA) recently released a position statement about biosimilars, saying it will work with stakeholders to support the acceptance of biosimilars as well as work to close knowledge gaps, given the burdensome cost of cancer care.

The 2-part proposal from Peter B. Bach, MD, and 3 coauthors published Monday argues that biosimilar competition is an economically inefficient way to achieve the goal of lower prices.

Last week, Health Canada approved Celltrion and Teva’s biosimilar rituximab, Truxima, for the treatment of adults with non-Hodgkin lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis.

The Center for Biosimilars® recaps the top news for the week of April 8, 2019.

Russian drug manufacturer Generium Pharmaceutical, which specializes in orphan drugs, announced yesterday that it has received Russian marketing approval for its biosimilar eculizumab, referencing Soliris, the most expensive orphan drug in Russia.

In its announcement, the drug maker said that its Udenyca sales are expected to be in the range of $36 million to $38 million.

Pfizer has launched its biosimilar trastuzumab, Trazimera, in Spain. The biosimilar became available to Spanish patients with early and locally advanced or metastatic HER2-positive breast cancer and HER2-positive metastatic gastric cancer on April 1, 2019.