Biosimilars

The FDA’s temporary Guidance for 503A compounding of shortage drugs was meant to be temporary and withdrawn once COVID-19 ended.

Individuals who are rituximab-naïve remained stable after 2 years of follow-up, the analysis shows.

Part 1 of this 2-part series examines USP <797> and <795> revisions for sterile and nonsterile compounding, veterinary compounding, FDA inspections of 503A pharmacies, and the interstate distribution of compounded prescriptions post Wellness Pharmacy v. FDA.

This method has proven economically appealing, but further confirmation of these findings is needed, according to investigators.

Sandoz intends to launch the latest Humira biosimilar in the United States on July 1, 2023.

Educating patients, providers improves acceptance, trust as number of approvals, indications grows

The treatment shows an acceptable toxicity profile and no new adverse events, according to results of analysis.

Pharmacists are the best resource at cancer center practices to ensure patients with cancer do not need to make the choice to stop or delay therapy due to financial reasons.

These alternatives to expensive biologic drugs can provide access to lifesaving treatments to more patients and cut costs for health systems.

A patient’s neurological symptoms diminished when he discontinued a biosimilar and started various new treatments.

The company is also launching Rezvoglar, a biosimilar to Lantus injection, for $92 per 5-pack of KwikPens.

The FDA has created an online, searchable database that contains information about biological products, including biosimilar and interchangeable ones.

A specialty pharmacy can effectively dispense, monitor, and follow-up with transplant patients who are maintained on the standard triple-drug immunosuppression regimen.

By binding to and inhibiting RANKL, denosumab decreases the production and activity of osteoclasts, resulting in reduced bone loss.

Biosimilars, staffing issues, and mail-order companies are key trends to watch.

Availability of TNF-alpha inhibitor biosimilars in Southern European markets led to lowered costs within the drug class, even after an increased consumption volume for these therapies.

Amjevita is approved for all indications of reference Humira except for hidradenitis suppurativa.

Pipeline includes more than 100 products encompassing bone health, cancer care, immunosuppressants, ophthalmology.

Carina Dolan, PharmD, BCOP, senior director for Clinical Oncology and Pharmaceutical Outcomes at Vizient Inc, discusses the highlights and big picture moving forward for hospitals and health-system pharmacies.

Research shows that some unsuccessful switches from reference products to biosimilars may be attributed to patient perceptions of reduced efficacy and safety.

YLB113 (Nepexto) produced significantly lower injection site reactions and injection site erythema compared with etanercept in patients with rheumatoid arthritis.

Big pharma companies have become more measured in their risk taking, with mergers and acquisitions gradually giving way to joint ventures and partnerships.

The subcutaneous formulation could enhance treatment options by providing high consistency in drug exposure and a convenient administration method.

Adalimumab-aacf (Idacio) is indicated for chronic conditions such as rheumatoid arthritis, plaque psoriasis, ulcerative colitis, psoriatic arthritis, hidradenitis suppurativa, and juvenile idiopathic arthritis.

Getting payers on board will be key to national biosimilar cost-savings potential.

Three key opportunities for oncology stewardship are dose rounding, implementation of biosimilars, and management of sites of care.

Generic small molecule drugs take advantage of abbreviated approval pathways and have markedly lower development costs compared to their reference products.

Presenters at the AMCP Nexus conference explore outcomes data and whether these medications should be substituted for reference products more frequently.

Bevacizumab-adcd (Vegzelma) is indicated for the treatment of nonsquamous non–small cell lung cancer; recurrent glioblastoma; metastatic colorectal cancer; persistent, recurrent, or metastatic cervical cancer; metastatic renal cell carcinoma; and epithelial ovarian, fallopian tube, or primary peritoneal cancer.

The biosimilar matches Prolia in efficacy, immunogenicity, pharmacodynamics, and pharmacokinetics in women who are postmenopausal with osteoporosis.