Cipla and its wholly owned subsidiary, Cipla USA, have launched Pomalidomide capsules, the generic equivalent of Pomalyst by Celgene Corporation, a Bristol-Myers Squibb company, in the US.
Pomalidomide capsules are indicated, in combination with dexamethasone, for the treatment of adults with multiple myeloma who have received at least two prior therapies, including a proteasome inhibitor and lenalidomide, and whose disease has progressed during or within 60 days of completing their last therapy.
The drug is also indicated for the treatment of adults with AIDS-related Kaposi sarcoma following failure of highly active antiretroviral therapy (HAART), as well as adults with HIV-negative Kaposi sarcoma.
Pomalidomide capsules are available in 1mg, 2mg, 3mg, and 4mg strengths.
“This launch reinforces Cipla’s long-standing commitment to expanding access to high-quality, affordable oncology therapies,” said Marc Falkin, CEO, Cipla North America.
“As we continue to build a comprehensive portfolio across the treatment continuum, our focus remains on improving patient outcomes, addressing barriers to care, and supporting continuity of treatment, including through co-pay assistance programmes for eligible patients,” he added.
The product will be manufactured at a Cipla-approved facility, supporting continuity of supply.
Cipla is participating in the PS-Pomalidomide Risk Evaluation and Mitigation Strategy (REMS) Programme, the same program followed by the innovator, to support patient safety and compliance with US Food and Drug Administration requirements.
The launch adds to Cipla’s growing portfolio of complex and differentiated products in the US, particularly across respiratory and specialty therapies.
In June, Cipla received US FDA approval for its Abbreviated New Drug Application (ANDA) for generic Advair Diskus (fluticasone propionate and salmeterol inhalation powder) in all three strengths—100/50 mcg, 250/50 mcg and 500/50 mcg.
Advair Diskus is a combination therapy indicated for the treatment of asthma and chronic obstructive pulmonary disease (COPD). The approval marked Cipla’s first dry powder inhaler (DPI) approval from its US-based manufacturing network, representing a significant milestone in the company’s expansion of complex respiratory capabilities in the US.
In April, Cipla received final US FDA approval for its ANDA for Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation. The product is the first AB-rated generic therapeutic equivalent of Ventolin HFA, marketed by GlaxoSmithKline.
Albuterol Sulfate Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in adult and paediatric patients aged four years and older with reversible obstructive airway disease, as well as for the prevention of exercise-induced bronchospasm in patients aged four years and older.
The approval further strengthened Cipla’s US respiratory portfolio and its presence in the albuterol inhalation category, with approved generics for both Ventolin HFA and Proventil HFA.
Also in April, Cipla received final US FDA approval for its ANDA for Nintedanib Capsules, 100 mg and 150 mg, indicated for the treatment of idiopathic pulmonary fibrosis (IPF). The product is the generic therapeutic equivalent of Ofev, marketed by Boehringer Ingelheim.
Earlier, in February, Cipla launched Liraglutide Injection, 18 mg/3 mL (6 mg/mL) single-patient-use prefilled pens, the generic equivalent of Saxenda (liraglutide injection).
Liraglutide Injection is a complex injectable peptide delivered through a multidose injector pen drug-device combination. It is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in patients meeting defined clinical criteria.
Image: Invagen Long Island Manufacturing Unit Two, which specialises in the production of tablets and capsules tailored exclusively for the United States market.
