Alvotech Increases Submissions Efficiency with Continuous Publishing

Alvotech achieved a 40% efficiency increase by implementing Veeva Submissions Publishing to streamline submission management. This accelerated submission processes across its product pipeline, spanning insulin and vaccines to monoclonal antibody cancer therapies. With an agile mindset, the biosimilars company went live in just 13 weeks.

Scaling submission output ninefold

To support growing submission volume, Alvotech implemented Veeva Registrations, Veeva Submissions, and Veeva Submissions Archive in November 2022. However, the company maintained a traditional publishing approach that did not efficiently scale with the business.

“The rapid [submissions] increase highlighted the need to manage higher volume efficiently, while maintaining quality and compliance without additional resources,” said Isabelle De Montazet, director of regulatory information management at Alvotech. The linear publishing process required content to be finalized and approved before being handed off to publishers. This often meant that validation errors, rework, or delays surfaced late in the process, when pressure was the highest to meet submission deadlines.

In June 2024, Alvotech implemented Veeva Submissions Publishing to accelerate and scale submission output, which increased ninefold from 2020. “I thought it [Veeva Submissions Publishing] was a good solution to support the submission process and financially interesting given the company’s size,” said De Montazet. “There were only two products to migrate at the time, with new biologic license applications (BLA) planned.” By shifting to continuous publishing on a unified RIM platform, downstream publishing and validation tasks run in parallel with upstream planning and authoring. This makes it easier for Alvotech’s team to catch issues earlier in the submission lifecycle.

Evolving roles and responsibilities for greater control

With a continuous publishing approach, publishers are involved throughout the entire submission lifecycle for greater visibility and control. They “have a better overview and understanding of the task which makes more sense in the preparation of the dossier,” highlights De Montazet. This elevates the publisher’s role to a submission manager, responsible for document workflows as well as publishing tasks. Submission managers are “more fulfilled in their daily work with greater task diversity, impact, and responsibility,” adds De Montazet.

Submission managers use submission content plans (SCPs) to efficiently prepare, track, and deliver submissions. “The submission content plan provides a visual and dynamic layout from which content managers can easily view and update statuses, and align with continuous publishing,” says De Montazet. Leveraging eCTD expertise, submission managers can use SCP templates to include all expected documents for a submission, even if details aren’t finalized. This helps streamline downstream publishing processes.

“It is easier to identify the delay, adjust the timeline, and regularly update information. So we get better control from a timeline point of view,” says De Montazet. “You can adapt quickly because you have a clear view of your dossier at any time.”

Accelerating submissions with continuous publishing

By implementing continuous publishing, Alvotech’s team submitted multiple post-approval changes and four major biologic license applications (BLAs) to the EMA, FDA, and other major markets. With 12 biosimilar products in the pipeline, the company is currently working on harmonizing data across the Vault Platform and implementing the Veeva Quality-RIM Connection.

With continuous publishing, Alvotech increased its efficiency by 40% year over year while using fewer resources. This transformation reduced pressure on regulatory teams, increased data quality, and improved process governance. Now everyone is “always speaking about the same thing,” adds De Montazet.

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