PPB issues urgent alert over falsified Roche Phesgo breast cancer medicine batch

KENYA—The Pharmacy and Poisons Board has issued a public safety alert after detecting a falsified batch of Phesgo, a breast cancer treatment, circulating within the Kenyan pharmaceutical market.

The regulator raised concerns that the product poses a serious risk to patient safety and urged immediate action from all stakeholders in the healthcare supply chain.

In its public notice, the Board instructed healthcare providers, pharmacists, distributors, and patients to stop using and distributing the suspected counterfeit batch identified as C5290S20.

It further emphasized that the product does not match any legitimate batch records from the manufacturer.

Medicine identification and quality concerns

Phesgo, manufactured by Roche, contains a combination of Pertuzumab and Trastuzumab and is used in the treatment of specific types of breast cancer.

The Board explained that genuine Phesgo is supplied as a ready-to-use clear to slightly brownish liquid for subcutaneous injection, which does not require any preparation before administration.

However, post-marketing surveillance revealed that the falsified version appeared as a white powder, a form inconsistent with the authentic product.

According to the regulator, this discrepancy confirms that Batch Number C5290S20 is not recognized within Roche’s official manufacturing system.

The Board warned that the falsified product may contain incorrect, insufficient, or harmful ingredients.

It also stressed that the quality, safety, and efficacy of the counterfeit medicine cannot be guaranteed, increasing the risk of treatment failure or serious adverse effects among patients.

Regulatory action and enforcement measures

The Pharmacy and Poisons Board stated that it is working closely with relevant investigative agencies to identify and take action against individuals or entities involved in the distribution of falsified medicines.

It reiterated that unauthorized procurement and circulation of medicines violates the Pharmacy and Poisons Act, Cap 244 of the Laws of Kenya.

In addition, the regulator called on procurement agencies, wholesalers, retailers, and healthcare facilities to source medicines strictly from licensed and verified suppliers.

It warned that non-compliance exposes patients to significant health risks and undermines the integrity of the national healthcare system.

Public reporting and safety guidance

The Board encouraged healthcare workers and members of the public to report any suspected substandard or falsified medicines through its official reporting platforms, including the online portal, USSD code *271#, mPvERS mobile application, email, and hotline services.

Acting Chief Executive Officer Dr Ahmed I. Mohamed reaffirmed the institution’s commitment to safeguarding public health.

He noted that collaboration from healthcare professionals and the public remains essential in ensuring the safety, quality, and effectiveness of health products circulating in the country.

Ongoing Concern Over Counterfeit Medicines

The alert comes amid sustained regulatory vigilance over counterfeit and substandard medical products in Kenya’s pharmaceutical supply chain.

Health authorities continue to strengthen surveillance systems to detect irregularities early and prevent harmful products from reaching patients in need of critical therapies.