FDA Issues CRL for Biocon Biologics, Viatris Avastin Biosimilar

Biocon Biologics and Viatris have taken another blow from the FDA after receiving a complete response letter (CRL) for their bevacizumab biosimilar referencing Avastin. Biocon Biologics announced the news in a statement for its investors.

The letter represents the second CRL in 2023 for the partners following the one sent concerning their recombinant human insulin biosimilar. Unlike the CRL for the recombinant human insulin biosimilar, which requested additional data to be submitted, the CRL for the bevacizumab candidate cited a failed manufacturing facility inspection.

According to Biocon Biologics, it has submitted a “comprehensive” Corrective and Preventive Action (CAPA) plan to the FDA and is “confident of addressing the observations within the stipulated timeframe.” The FDA did not identify any issues with the preclinical and clinical trial results that were submitted in the dossier submitted as part of the biologics license application for the bevacizumab product.

Although the United States will have to wait longer for the Biocon Biologics/Viatris bevacizumab biosimilar, it is currently available in Canada after its launch in May 2022, where it is marketed under the name Abevmy. If approved in the United States, it will be the fifth bevacizumab biosimilar to receive FDA approval.

Alvotech, an Iceland-based company, also received a CRL citing the need for manufacturing facility improvements, this time for an adalimumab biosimilar (AVT02). However, although a CRL is bad news, it doesn’t mean that it will hinder a company’s resolve. After receiving the CRL in September 2022, Alvotech rescheduled its FDA inspection for March 6 and is expected to receive the FDA’s approval decision by April 13, allowing for the company to stick to its planned July 2023 launch timeline.

The FDA has been working hard to catch up on their backlog of manufacturing facility inspections, including the implementation of remote inspections, that occurred as a result of travel restrictions imposed by the COVID-19 pandemic.

“The other piece about the inspections, as we have heard from the FDA in our meetings, is that they plan to get all of the inspection backlog completed by the end of this year for the fiscal year. So, we are cheering them on and also going to hold them accountable to do that, and especially with biosimilars because they're so important for patients and like we said cost savings. But yes, that's a key piece for us,” said Julie Reed, executive director of the Biosimilars Forum, in an interview with The Center for Biosimilars®.

Biocon Biologics Financial Results for Q3FY23

In addition to the CRL, Bengaluru, India-based Biocon Biologics published positive financial results for the third quarter of fiscal year 2023 (Q3FY23). Biosimilar revenues were up 54% and generics were up 23% from the same quarter last year.

Overall, the company made Rs 3,020 Crore ($364,545) in revenue. Biosimilars accumulated Rs 1,507 Crore ($181,843) and generics generated Rs 718 Crore ($86,657,071).

“While our biosimilars portfolio continues to gain market share in the U.S. and EU, our business in the Emerging Markets is also on a growth trajectory with product launches in 8 new markets this quarter," said Shreehas Tambe, CEO and managing director at Biocon Biologics, in a statement on the results.

Viatris and Biocon Biologics Partnership/Acquisition

The news comes after the completion of Biocon Biologic’s acquisition of Viatris’ biosimilars portfolio. The companies entered a Transition Services Agreement in March 2022, during which Viatris will provide commercialization assistance and transition services for a 2-year period to ensure business continuity for patients and other stakeholders. Biocon Biologics will be responsible for commercial, regulatory, and other related services.

“The closing of our biosimilars transaction with Biocon Biologics marks the next natural step in the evolution of our collaboration together… As we look to Viatris' future, we are also excited to focus our energy, resources, and efforts on executing our own strategy of moving up the value chain and providing access to more complex and novel products,” commented Rajiv Malik, MPharm, president of Viatris.

The companies are also partners for Nepexto, an etanercept biosimilar referencing Enbrel, and Semglee, an insulin glargine biosimilar that was the first biosimilar to be approved as an interchangeable product in the United States. Biocon Biologics has also developed a recombinant human insulin biosimilar (Insugen), which won a tender contract in Malaysia.