Dariusz Głogowski, country manager of Alvogen Poland, discusses his successful strategy to introduce biosimilars onto the Polish market and the nation’s moves to reward this new wave of generics. Furthermore, he highlights the strategic importance of Poland in the region as the company’s footprint continues to grow and highlights the possibilities in the future for local acquisitions, as well as the business approach that has triggered excellent results for the company in neighbouring markets.

What have been the key milestones for the affiliate since you took over the country manager role in 2014?

After completing my studies as a medical doctor, I moved into the pharmaceutical industry in 1994 with Servier as medical representative, and throughout the years I have worked at some large companies, such as Polpharma and Menarini. In 2010, I became general manager of PharmaSwiss before it was acquired by Valeant, and in 2011 the general manager of Farma-Projekt. I was able to restructure this company from near bankruptcy, before it was acquired by Recordati in 2012.

In 2014, I made the move to becoming the country manager of Alvogen. The affiliate was registered in Poland in 2011, and started operations in 2012. My predecessor had a career based in the hospital business sector and he chose to concentrate in this area. Unfortunately, the falling prices in this sector caused large losses, to the point Alvogen was even considering stopping Polish operations altogether.

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During the recruitment process prior taking up this role, I proposed to focus on biosimilar and high speciality oncology products. Therefore, Alvogen Poland began to promote two biosimilar lines, called BIO and ONCO concentrated on gastrology and oncology, while in the meantime having a controlled approach to the hospital market, based around results and profitability. Additionally, we expanded the portfolio in the non-reimbursed field to balance our market approach towards biosimilars.

If you look at the Poland, for the past 20 years the Polish pharmaceutical market has grown, except for 2012. The 2011 reimbursement act caused a nine percent drop, and many people were hugely affected. In 2016, a new reimbursement act was proposed and planned to be introduced in 2017, though we are still waiting for this change, and the industry overall is unsure of what will be its effect. There have been changes as well in the Ministry of Health, and now we are awaiting the decisions of the new undersecretary of state, Marcin Czech, who is responsible for drug policy and the new minster of health, Łukasz Szumowski.

How successful have your proposed biosimilar launches been for Alvogen Poland?

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When I took over the position, we had three people in the field, and five in the office. My role was to convince people to come to the company, a challenging task considering we were a complete unknown in the polish pharmaceutical ecosystem.

Starting from zero, we are now a company everybody knows, especially in the biosimilar and gastroenterology field of medicine, where we are extremely successful. This is due to the correct strategy, right people, good contacts with key polish stakeholders and an amazing product, like biosimilar infliximab®, Inflectra®. This biosimilar has been amazingly well received to the point that we are now accessing more patients than Abbvie, being the owners of the reference biologic adalimumab product, Humira®. In fact, within Alvogen, we have the highest number of patients utilizing Inflectra® within the CEE region.

What is the strategic importance of Poland within the region?

When I came to Alvogen in 2014 the company was in the red. Now, we are an affiliate that is highly profitable, mainly thanks to Inflectra® and our oncology business. We are the fourth market in the CEE, behind Russia, Romania and Hungary – although – this year we should move into the third position. Amazing result!

In Romania, Alvogen purchased a significant player in the market and in Hungary and Russia they have acquired a few companies. In Poland, we have achieved a great success while only purchasing two products. Therefore, this shows the amazing potential of the Polish market!

Overall, our most important product is the aforementioned, Inflectra®, and our biosimilar filgrastim, Nivestim® in the oncology field. Furthermore, two years ago, we launched the first and only equivalent of Zoladex® on the Polish market to combat prostate cancer, named Reseligo®. Thus far we already have a quarter of the market in this field, and our share continues to grow.

How advanced is Poland in its biosimilar regulations?

Alvogen has always supported biosimilars from the start, and our success is connected to biosimilar approval at the European level. Biosimilars are an effective way of establishing a high-quality generic solution, that in-turn generates excellent savings for the healthcare system.

In Poland, there has been support from the government regulator to introduce biosimilars, and the Polish approach is like any normal generic. This involves the blanket generic rule that the first equivalent on the market must carry a cost of 25 percent less than the original – a regulation Alvogen Poland has been able to follow.

Within the Polish healthcare ecosystem, the use of biosimilars is in certain therapeutic groups that cover a limited number of patients. In Poland, most of biosimilars are reimbursed throughout the system of so called therapeutic programs. In these programs, the access of patients is limited comparing to approved indications. For example, Crohn’s disease has a large patient window, through under these programs, this window is made significantly smaller. Therefore, previously patients only received one year’s treatment, compared to Norway – for example – where patients are given treatment for their entire lifetime.

Nevertheless, we invested into a thorough health technology assessment (HTA) of Inflectra®’s effect on Crohn’s disease in Poland, and after two-year effort were able to extend the therapeutic window for patients from one to two years. We were also able to do the same for ulcerative colitis, extending the treatment period from three to twelve months.

How is Alvogen integrating itself within the Polish healthcare community at a greater level?

We are very active in cooperating with key opinion leaders and patient organizations, that in-turn has helped us in our own mission of helping treat more patients. For example, in the case of Inflectra®, key opinion leaders witnessed that the drug was drastically improving patients when they were given access to the therapy, though after one year, when the treatment ended, the patient had no other choices. Therefore, the move to extend therapy to a two-year window was very important, and our integration in Poland helped us achieve this historic success.

Alvogen is renowned for its partnership and acquisition style. What potential is there for Poland to take a further part in this approach?

Alvogen is extremely proficient in business development. For example, our flagship product Inflectra® was licenced from Hospira® for CEE, and since Hospira® has been purchased by Pfizer, we are now partners with Pfizer. Furthermore, the company is investing in its own biosimilars with the impressive R&D site in Iceland through our biosimilar branch company, Alvotech.

In Poland, I am constantly looking for business opportunities, and have talked with many different companies about possible licence agreements and acquisitions – like has already been done by Alvogen in Russia, Hungary and Romania with company acquisitions. Nevertheless, despite the many proposals, no target has been positive enough for us to find a deal suitable for Alvogen.

Alvogen is a fairly young company, being established in 2009. How do you position the company in Poland moving forward?

We have built our position here step by step, going from being Mr. Nobody in Poland to having a strong presence in gastroenterology, oncology and now, urology. Furthermore, we are every present in social settings. For example, children each year in oncology wards across Poland create artworks to purchase, with the money going back to the kids. Alvogen purchases a huge amount of these art pieces, and we are ever present in many other social activities in Poland, a concept we have gladly inherited from the HQ.

What is your strategy moving forward for Alvogen Poland?

A big portion of our business is reimbursed; therefore, our success is heavily connected with government policy, which at times in Poland can be unpredictable. To counter this, we will be expanding our OTC portfolio by launching four new products in 2018, making us less dependent on government decisions.

Additionally, we will be setting up our own supply warehouse in Poland, ensuring Alvogen Poland is more complete and efficient as an organization.

You have worked in many different companies throughout the years. What is the special quality that makes Alvogen stand out?

Alvogen’s style and my own are extremely similar; an entrepreneurial approach that allows me to take my own decisions and choose my own strategy on products and operations. This allows decisions to be made quickly, and we believe this style is a lot more effective that the slow movement of big pharma. Furthermore, moves made at the local level are generally more informed than those made by HQ.

All in all, this gives me responsibility and promotes accountability throughout the organization. I am then able to pass this accountable approach onto my team, and overall it makes Alvogen a great place to work and I love it!