News

This is the third Form 483 Biocon has received for the insulin plant in 3 years.

The quantitative comparison study compared 4 different, commercially available enzyme-linked immunosorbent assays used in therapeutic drug monitoring to detect drug concentration and antibodies to infliximab in samples of drug diluted in serum.

Lichen planopilaris (LPP) is a type of scarring hair loss that occurs when lichen plaus, a relatively common inflammatory skin disease, affects areas of skin where hair grows. It destroys the hair follicle and replaces it with scarring, resulting in permanent hair loss. LPP’s causes and pathology are unknown.

The use of low-dose methotrexate in rheumatoid arthritis dates back more than 30 years, but despite these decades of clinical use, data on adverse effects have come mostly from observational studies rather than randomized controlled trials (RCTs), the authors say.

Antitrust claims are a product of federal statute, said the Third Circuit Court of Appeals, in reinstating a Walgreens and Kroger antitrust lawsuit against J&J over its branded infliximab, Remicade.

The study compared the stool samples of patients with ulcerative colitis (UC) with patients with familial adenomatous polyposis. Both groups may have colectomies, but only the patients with UC have inflammation that may return even after surgery.

The guidelines, based on clinical evidence, are a pathway to a shared decision-making process between patients and their physicians, said the American College of Rheumatology (ACR).

Ultimately, the Purple Book is supposed to include all Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) regulated products, including transition biological products.

A recent year-in-review article outlines studies published in 2019 about nonmedical switching from originator biologics to biosimilars in rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis.

The Center for Biosimilars® recaps the top stories for the week of February 17, 2020.

Although the US biosimilar market had a slow start, the booming industry in Europe shows the potential for the market here. However, in order to level the playing field, more policy changes and legislation are needed to prevent originator products from crowding out competitors.

With Trazimera in place, Herceptin now has 3 biosimilar competitiors.

Pharmaceutical giant AbbVie reports strong revenues for next-generation products the company hopes will provide fill-in revenue as Humira (adalimumab) sales decline and more biosimilars to the blockbuster arthritis drug enter the market.

The FDA said it was no longer necessary to include the interpretation of the term “chemically synthesized polypeptide” as first proposed in December 2018.

The review found no increased risk of cancer when looking at both keratinocyte cancer and lymphomas in patients on biologics vs conventional therapy. Overall, however, patients with psoriasis appear to have a slightly increased risk of certain cancers.

Because of the high cost of biologics, the authors recognized a need to provide access to evidence-based information on biosimilars for healthcare providers working with patients with inflammatory bowel disease.

The Office of Pharmaceutical Quality, charged with strengthening and building public trust in the US supply of medicine, notes that March 23, 2020, will mark a key turning point in the way that many biologics are licensed.

Which Medicaid plans benefit the most from the current drug rebate structure and are incentivized to prescribe branded prescriptions? Researchers used the issue of follow-on insulin glargine as well as glatiramer acetate to find out.

The Center for Biosimilars® recaps the top stories for the week of February 10, 2020.

Hurdles to a vibrant biosimilar market are not as insurmountable as they appear.

Previous studies demonstrating equivalence of SB4 to etanercept in pharmacokinetics and safety have used pre-filled syringes, but these devices may be difficult for some patients to use if they have reduced hand dexterity due to the challenges of living with rheumatoid arthritis.

By 2023, patents on nearly 20 oncology biologics will expire, which could lead to more biosimilars in cancer care and therefore reduced costs, according to a review article.

The study aimed to provide insight into the real-world patterns of biosimilar initiation in patients with rheumatoid arthritis (RA) and ankylosing spondylitis (AS) in Korea by identifying patient characteristics and other factors associated with starting biosimilars using a logistic regression model.

Updated guidelines from the European League Against Rheumatism (EULAR), based on new evidence and a review of the literature from 2016 to 2018, address recommendations on the use of disease-modifying antirheumatic drugs and glucocorticoids to treat patients with rheumatoid arthritis (RA). Included is guidance on mono- and combination therapies, treatment strategies, and tapering treatment.

The agency will now review and act on original 351(k) biologics license application (BLA) supplements with clinical data within a 6-month time frame. Originally, such supplements had a 10-month goal date for review. In addition, applicants can now request the FDA refrain from taking action on supplements of 351(k) BLAs before a certain date.

The Center for Biosimilars® recaps the top stories for the week of February 3, 2020.

Bio-Thera Solutions announced that a phase 3 clinical trial comparing the efficacy and safety of its bevacizumab biosimilar, BAT1706, to the reference product (Avastin), returned positive top-line results.

Merck markets a biosimilar infliximab, Renflexis; a biosimilar trastuzumab, Ontruzant; and a biosimilar etanercept, Brenzys, in partnership with Samsung Bioepis.

Reference pricing may shift the mix of drugs dispensed from those offering the highest rebates to pharmacy benefit managers to those offering the lowest prices to employers and employees, according to a new study published Wednesday.

The FDA and the Federal Trade Commission (FTC) will work more closely to support a more competitive market for biosimilars and interchangeable products. In addition, the FDA published draft guidance for industry about how to advertise and promote biologic products truthfully and announced a public workshop.