Polpharma Biologics: The Polish Biosimilar Powerhouse

Fortified by an acquisition, Polpharma Biologics, a contract development and manufacturing organization (CDMO) that specializes in producing biologic drugs in partnership with other companies, is growing at a rapid rate.

The company, with facilities in Gdańsk and Warsaw in Poland and Utrecht in the Netherlands, licenses out its Biosimilars and provides CDMO services to develop its products in compliance with FDA and European Medicines Agency standards for its partners, who make the decisions on what markets the products should compete in.

“We have to make sure that we're developing and producing enough high quality molecules for [our partners]. We label it, we ship it, we make sure that everything gets to where it needs to be,” said Alexandra Moulson, vice president of Strategy, Programs and Portfolio at Polpharma Biologics, in an interview with The Center for Biosimilars^®.

Recently, the company completed the integration of Bioceros, a Dutch company Polpharma Biologics acquired 4 years ago. Bioceros’ Utrecht facility became the home for Polpharma Biologics’ cell line development platform. Polpharma Biologics continued to use the name Bioceros, but recently dissolved that name to better establish to the biopharmaceutical world that Polpharma Biologics’ 3 facilities were all part of the same company.

Moulson said that Polpharma Biologics continues to grow and aims to eventually have as many as 1000 employees. Currently, there are roughly 500 at the Gdańsk plant and about 40 to 50 employees at the Utrecht facility. She said the Warsaw plant is on track to have 200 employees by the end of 2020.

“If you turned the clock back 2 years, it was definitely less than half that size,” said Moulson, commenting on the company’s rapid expansion.

Polpharma Biologics currently has 7 biosimilars in its pipeline including a ranibizumab molecule (FYB201), which was developed in partnership with Bioeq for the treatment of wet age-related macular degeneration.

The company is also in the process of developing a natalizumab molecule in collaboration with Sandoz. The drug is used for treatment of Crohn disease and multiple sclerosis. Polpharma Biologics is also developing biosimilars for ustekinumab, for the treatment of plaque psoriasis and psoriatic arthritis, and vedolizumab, for the treatment of ulcerative colitis and Crohn disease. It has 3 other molecules in early stages of development for use in oncology.

Company History and CDMO Services

Although decisions including drug prices and what markets products in Polpharma Biologics’ portfolio will compete in are left up to its partners, who own and license the products, the company is willing to assume the development, manufacturing and monetary risks with its biosimilars to ensure the medications that patients need are developed, according to Moulson.

“Other companies come to us and want CDMO work in the biologics space because we know what we're doing with our biosimilars background, but our goal is not to become a 100% biosimilar company. Our goal is to become a leading biologics manufacturer and biosimilars are a key part of what we do,” she said.

Moulson said that on average, for every 6 novel biologics the company develops, it will develop 1 biosimilar. However, she said this is not a hard-and-fast rule, because the types of molecules Polpharma Biologics develops are really dependent on which ones its partners want.

Polpharma Biologics, founded in 2013, is a spin-off from Polpharma, which manufactures active pharmaceutical ingredients, prescription drugs, generics, over-the-counter medicines, and medical devices. Moulson said that carrying the Polpharma name gives the company brand recognition.

Some employees were with Polpharma before the split. Since then, many more have joined from big-name manufacturers, including Moulson, who previously worked as head of Strategy and Novartis Collaborations at Sandoz.

“One of the goals that we have within the company is to take the knowledge that a lot of the management team has from working in other markets and other companies and…bring that knowledge into the company’s Polish group, who are fantastic scientists, and make sure that they are well equipped to move these molecules forward [through development],” said Moulson.

COVID-19 Impacts

Moulson said that, surprisingly, Polpharma Biologics was mostly unimpacted by the coronavirus disease 2019 (COVID-19) pandemic. The company was able to complete recruiting for its phase 3 natalizumab trial before the pandemic took hold in Europe and has run smoothly ever since.

However, in March, Polpharma Biologics did voluntarily halt recruiting for a phase 1 trial for its natalizumab biosimilar that it was running concurrently with the phase 3 trial. Moulson said the decision was made because this phase 1 trial involves testing on healthy volunteers.

“We felt it was the right thing to do for the volunteers because we’re giving them a drug that we know is an immunosuppressant and we don’t want to then allow these people to be exposed to a potentially [compromised] situation,” said Moulson.

Luckily, as Europe has begun restarting its economy, the trial has recently restarted. Although the timeline for submission for the candidate is now skewed, Moulson said she is confident that Polpharma Biologics can catch up and still submit for approval on schedule.

Forward Expansion

Moulson said that the company does its best to work on biosimilars in niche markets, where they don’t expect there to be much competition, in order to create a balance between making a selection that a future partner will want, one that will benefit patients, and what would be most cost-effective to produce.

Moulson also expressed that she would like to see more of Polpharma Biologics’ products competing in developing markets outside of the United States, United Kingdom, and European Union. However, she said that navigating different regulatory, distribution, and clinical standards can make developing products for those markets difficult.

Moulson said the company’s biggest challenge has been the speed of hiring while trying to maintain the distinct company culture as it continues to grow.

“It’s such a cool place to work and I really mean that. The people are genuinely caring and friendly and really want to make a difference. It’s very different to every other company I’ve worked in so far. And as we bring in new blood into the company, we need to be selective not only on skills, but also in the way that they think and behave because we want to maintain that unique culture,” said Moulson.