Biosimilars

Perhaps the most significant development in the pharmaceutical industry in decades, crops of biosimilars are being approved and are ready for distribution. What lies next, in terms of legislation and the impact on pharmacists, remains to be seen.

The FDA is the first regulatory agency globally to approve natalizumab-sztn as a biosimilar for natalizumab.

The Mylight phase 3 trial confirmed that there was no clinically meaningful differences between aflibercept and its reference biologic, Eylea, for patients with wet macular degeneration.

The launch of adalimumab biosimilars are expected to affect spending in the immunology space.

Pharmacists will have the opportunity to use their knowledge of biosimilars to reinforce their benefits, safety, and efficacy.

Many studies with a stated goal of advancing child health care in administratively-defined minors have no clinical value and may even harm young patients.

Although SB5 is an effective treatment for plaque psoriasis, it is recommended that patients consider the potential risks and adverse effects.

With the continued advancement and approval of cell and gene therapies, the need for trustworthy microbiology quality control solutions is at an all-time high.

Study finds patients with cancer feel reassured that biosimilars provide a safe, adequate, and cost-effective alternative to the pricier reference drug.

In terms of science and technology, the health care community has everything needed to clinically implement pharmacogenomics testing.

A panel of experts discuss the state of biosimilars today and the importance of standardizing knowledge of the field.

An increased demand for methylphenidate products as a result of Adderall shortages has led to a short supply of some popular products, including Ritalin and Concerta.

Pharmacists must carefully consider safety concerns and patient privacy.

Therapeutic drug monitoring is a growing and vital area for pharmacists to become involved in to increase patient success with inflammatory bowel disease remission.

FDA approvals of these biosimilars started in 2016, but only 1 such product has successfully launched.

Express Scripts recently announced the addition of 3 Humira biosimilars to its main formulary.

If finalized, the regulation would potentially reduce prescription nonadherence and accidental misuse.

Adalimumab-adaz HCF in the 100 mg/mL strength is approved for indications that are no longer covered exclusively for the reference Humira after July 2023.

Investigators found that the first biosimilar of trastuzumab, trastuzumab-anns (Kanjinti; Amgen), did maintain a strong and persistent advantage over the other 4 biosimilar entrants.

The Act4Biosimilars Action Plan highlights major challengers in preventing access to biosimilars and actionable steps to accelerate the adoption by overcoming these challenges.

Law aims to encourage competition in the pharmaceutical industry, making it easier for generics to enter market.

Despite having a lower cost of development than the innovator, romiplostim biosimilar has comparable efficacy and safety in patients with chronic immune thrombocytopenia.

Pharmacogenomics is gaining support in mental health and polypharmacy, where the data make a strong case for improvements in clinical and economic outcomes.

SB15 had a comparable safety, pharmacokinetics, and immunogenicity treatment profile to AFL for age-related macular degeneration.

Upadacitinib 15 mg once daily had a better clinical response compared to adalimumab 40 mg every other week at 12 weeks in 3-year follow-up data among patients with rheumatoid arthritis.

As more becomes known about Crohn disease, treatment modalities have evolved with biologic monoclonal antibodies becoming a key part of guideline- and evidence-based medicine.

With so many radical developments in medicine and technology unfolding at once, the role and potential of the pharmacy as we know it is evolving at breakneck speed.

It is the second anti-TNFα biosimilar approved for use in the US.

In a single-center study, investigators reviewed charts of 25 children with inflammatory bowel disease transitioning from infliximab to the biosimilar infliximab-dyyb for maintenance.

Adalimumab-adbm (Cyltezo Pen; Boehringer Ingelheim) is approved by the FDA as an interchangeable biosimilar to Humira.