Novartis Reports 31% Growth in Biosimilar Division

In the first quarter of 2020, the coronavirus disease 2019 (COVID-19) did not put a “material” crimp in the financial picture for Novartis, which reported biopharmaceutical net sales, including biosimilars, of $450 million, up 31% from the comparable, year-ago quarter.

Novartis develops and retails biosimilars through its Sandoz arm. Sandoz net sales for the quarter were $2.5 billion, up 9%.

The company said much of its biopharmaceutical growth was driven by double-digit earnings in Europe, where the company has 8 biosimilars on the market. Novartis has 2 biosimilars on the market in the United States: Zarxio, a filgrastim product launched in 2015; and Ziextenzo, a pegfilgrastim, which was launched in November of 2019.

Novartis previously reported full-year 2019 global sales of biopharmaceuticals of $1.4 billion, up 27%, also largely fueled by growth in Europe and the United States. The 2 key drivers of that progress in Europe were the company’s rituximab (Rixathon) and etanercept (Erelzi) biosimilars. In the United states, growth was driven primarily by Zarxio. Sandoz has previously indicated high confidence in the US market for biosimilars.

Overall Sales of $12.3 Billion

Overall, Novartis reported net sales of $12.3 billion for the first quarter of 2020, up 11% and representing net income of $2.2 billion, up 16%.

The company said its financial position was not materially affected by COVID-19. However, “COVID-19 did result in increased forward purchasing by customers, including at the patient level, as some patients filled prescriptions to cover a longer period of time,” Novartis said.

The company said it had implemented strong supply chain measures to mitigate disruption and provide for adequate inventory during the pandemic, and that it did not anticipate supply chain disruption “for the majority of the portfolio at this time.”

Clinical Trials Slow Down

The company reported slowdowns in new patient enrollments in clinical trials and startups of new trials, although it said clinical trials are continuing and the company is closely monitoring more than 500 ongoing trials in 70 countries.

“At this time, we remain confident the impact on our ongoing clinical trials is manageable. Looking ahead for the remainder of the year, we do not expect delays in our planned 2020 regulatory submissions,” Novartis said.

In 2019, Novartis spun off its Alcon eye-care business and terminated a deal with Aurobindo Pharma to trade its Sandoz US generic oral solids and dermatology businesses.

In the United States, Sandoz has 2 approved-but-not-yet-marketed biosimilars: Hyrimoz, an adalimumab copy, expected to come to market in 2023; and Erelzi, an etanercept biosimilar, sales of which cannot move forward until patent issues are resolved. Both of these are currently available in Europe.

The Sandoz biosimilar pipeline includes several candidates in phase 3 clinical trial development. These include a subcutaneous denosumab candidate for bone disease, intravenous trastuzumab for breast and gastric tumors, and intravenous natalizumab, a monotherapy for relapsed multiple sclerosis and Crohn disease.

In a 2019 interview with The Center for Biosimilars®, Sandoz’s Sheila Frame, MBA, vice president of marketing, market access, and patient services, and William Yoon, PharmD, MBA, head of external engagement and medical advocacy, reflected on the company’s progress and potential with biosimilars.