Business

Biocon’s net profits for the past quarter dropped by 51%, according to a statement made by the Bangalore-based drug manufacturer.

July was a busy month for biosimilars targeting rheumatology indications; this month saw a product launch, developments in the legal realm, new clinical data, and prospective changes to Medicare reimbursement.

On Thursday, the Oncology Business Review (OBR) hosted a panel discussion, “The Advent of Biosimilars in Oncology: Planning Proactively for Change.”

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of July 24, 2017.

Boehringer Ingelheim announced today that it has enrolled its first patient in a study to demonstrate interchangeability of its biosimilar adalimumab candidate, BI 695501, with the reference adalimumab (Humira).

A recent report prepared by the Analysis Group sought to describe the current pipeline of biopharmaceuticals under development that could benefit US-based patients within the next 5 to 10 years.

Merck today announced the US launch of its biosimilar infliximab, Renflexis, which it developed under a joint venture with Samsung Bioepis.

The FDA has granted Merck’s insulin glargine (Lusduna Nexvue) tentative approval. Merck says that its follow-on basal insulin has met all required regulatory standards of clinical and nonclinical safety, efficacy, and quality for follow-on biologics.

Last week’s Oncologic Drugs Advisory Committee recommendation that the FDA approve 2 biosimilar treatments brought Swiss drug maker Roche a step closer to inevitable competition from biosimilar treatments.

A new report from GlobalData UK indicates that the market for HER2-positive breast cancer treatments could grow from $6.4 billion in 2015 to $9.89 billion in 2025, a compound annual growth rate (CAGR) of 4.4%.

Celltrion Healthcare, the marketing subsidiary of Celltrion Inc, has secured approximately $886.3 million—well over a previously projected $713 million—in its July initial public offering of 24.6 million primary shares.

Spherix Global Insights’ recently released survey of 103 US gastroenterologists reveals that practitioners project significant growth in the use vedolizumab, golimumab, and Pfizer’s Inflectra, an infliximab biosimilar, for the treatment of ulcerative colitis over the next 6 months.

France’s health regulatory body, the French National Agency for Medicines and Health Products Safety (ANSM), found that Biocon has failed to comply with good manufacturing practice requirements for 3 of its biosimilar products manufactured at the company’s Bommasandra facility in Bangalore, India.

The 9 top-selling drugs of 2016 include numerous biologics. Learn what these drugs earned, and how biosimilars are impacting their global sales.

Samsung Bioepis is reportedly undertaking shorter clinical trials in order to gain faster biosimilar approvals as the company seeks to compete with rival developers and to realize its first annual profits.

Biopharmaceutical medicines represent a growing share of the global pharmaceutical market, with $228 billion in global sales in 2016. As many of these products face the loss of patent protection, biosimilar versions of these molecules may now enter the market, causing a shift in market share and driving changes in pharmaceutical companies’ strategies.

In the wake of Coherus’ 30% reduction in workforce last week—a move that followed the company’s complete response letter from the FDA regarding its CHS-1701, a pegfilgrastim biosimilar candidate—the California-based biosimilar developer has sustained yet another blow to its business.

An FDA official has said that the agency expects interchangeable biosimilars to come to market within 2 years and that the first interchangeable biosimilar will likely be reviewed by an FDA advisory committee of outside experts.

Just 2 weeks after Coherus BioSciences announced that it had received a complete response letter (CRL) from the FDA in response to its biologics license application for a pegfilgrastim biosimilar candidate, the company has laid off 51 employees, or approximately 30% of its workforce, in a bid to cut its operating costs by $10 million.

Today, Sanofi and Regeneron announced that the European Commission has granted marketing authorization for the companies’ sarilumab (Kevzara), which is approved to treat severely active rheumatoid arthritis, and which outperformed Humira in a phase 3 trial.

Earlier this month, Biocad obtained a marketing authorization for its rituximab biosimilar in Bolivia and Honduras. The product, USMAL, will be available to patients within months. Yet the Russian firm sees roadblocks ahead for US market entry.

The FDA rejected, for a second time, Pfizer’s application for approval of its biosimilar epoetin alfa (Epoetin Hospira), a colony-stimulating factor indicated for anemia, biosimilar to Epogen and Procrit.

FDA Commissioner Scott Gottlieb, MD, has unveiled a new plan to facilitate increased competition in the prescription drug market through approval of more lower-cost, generic medications.

Worldwide prescription drug sales could reach $1.06 trillion by 2022, according to a new report. This earning represents only a 6.5% compound annual growth rate, and biosimilars may well play a significant role in curbed growth.

At the 8th Annual Summit on Biosimilars, a panel of legal experts reviewed lessons learned from the first 18 months of biosimilars in the United States, and looked ahead to the question of how these drugs will gain acceptance and market uptake.

Pharmaceutical manufacturers, pharmacy benefit managers, and various trade groups respond to the recent Supreme Court decision on the 6-month marketing rule post FDA approval for biosimilars.

Sandoz announced today that its biosimilar rituximab product has been approved by the European Commission to treat blood cancers and immunological diseases.

A viewpoint published in JAMA explains why biosimilar drugs approved in the United States for the treatment of chronic diseases may not result in expected cost savings.