Month: November 2024

…………catching up on FDA approvals

The FDA has approved a new therapy, Imuldosa (ustekinumab-srlf) from Accord BioPharma Inc., as a biosimilar to Janssen Biotech’s Stelara. Imuldosa is available in a subcutaneous form as well as an infusible.  

The approval of Imuldosa marks the fifth ustekinumab approval for the US. 

Imuldosa is slated to launch in May 2025 according to sources.

Imuldosa is indicated for—– 

Adult patients with:

• moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy;
• active psoriatic arthritis;
• moderately to severely active Crohn’s disease; and
• moderately to severely active ulcerative colitis.
• Pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; and active psoriatic arthritis.

It is noted that prescribing information specifies subcutaneous dosing and administration for Psoriasis and Psoriatic Arthritis while specifying intravenous dosing instructions for Crohn’s Disease and Ulcerative Colitis.

CLICK HERE for prescribing information

While Imuldosa did not receive a Black Box warning there are a number of warnings and precautions consistent with the other previously approved Stelara biosimilars.

Pricing and distribution plans were not announced.

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FDA Approves Imuldosa, a Biosimilar to Stelara

CLICK HERE to read the article

Announcements for newly approved specialty drugs often state that the product will be available through specialty pharmacy in limited distribution. However, the early press releases rarely specify the specialty pharmacy(ies) selected as the designated partner(s).

Here are five LD deals that have been publicly confirmed subsequent to their approvals.

DirectRx to Distribute Ohtuvayre

DirectRx is now part of the U.S. pharmacy network distributing Ohtuvayre (ensifentrine), a newly approved therapy for chronic obstructive pulmonary disease (COPD). The Verona Pharma therapy was cleared by the U.S. Food and Drug Administration as an inhaled maintenance therapy for adults with COPD.

Amber Specialty Pharmacy to Distribute Ohtuvayre

Amber Specialty Pharmacy has announced that it has been named by Galderma to distribute Nemluvio (nemolizumab-ilto) for the treatment of Prurigo Nodularis in adults. The condition is a chronic, debilitating skin condition.

Orsini Specialty Pharmacy Exclusive Distributor for Miplyffa

Orsini Specialty Pharmacy has been chosen as the exclusive provider for Miplyffa (arimoclomol), the First FDA-Approved Treatment for Niemann-Pick Disease Type C, an ultra-rare and progressive neurodegenerative disease. MIPLYFFA is indicated for use in combination with miglustat for the treatment of neurological manifestations of NPC in adult and pediatric patients 2 years of age and older.

Biologics by McKesson to Distribute Voranigo

Biologics by McKesson has been selected by Servier Pharmaceutical as a specialty pharmacy partner for Voranigo (vorasidenib). Voranigo is approved for the treatment of adults and pediatric patients 12 years of age and older with grade 2 astrocytoma or oligodendroglioma and a susceptible isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation following surgery including biopsy, sub-total resection, or gross total resection.

ONCO360 to Distribute Voranigo

Onco360 has also been selected by Servier Pharmaceutical as a specialty pharmacy partner for Voranigo (vorasidenib).