AbbVie ABBV is presently focused on strengthening its immunology portfolio. While its anti-inflammatory drug Humira continues to be a key revenue driver of the company’s sales, it is set to lose exclusivity in the United States next year.
AbbVie’s flagship product, Humira, is approved in the United States and Europe for several autoimmune diseases like rheumatoid arthritis (RA), active psoriatic arthritis, active ankylosing spondylitis and Crohn’s disease (CD). The drug accounted for nearly 37% of total 2021 revenues.
In the international markets, AbbVie is already facing direct biosimilar competition in Europe and other countries, resulting in a loss of product revenue. In the first half of 2022, international sales of the drug declined 18.6%. International sales were affected by the launch of several direct biosimilar drugs in Europe by other pharma companies, including Amgen AMGN, Sandoz and Biogen BIIB.
Companies like Amgen, Sandoz and Biogen were the first to start commercializing a Humira-biosimilar in Europe in 2018. Amgen, Biogen, Boehringer Ingelheim, Pfizer, Sandoz and many other companies also received FDA approvals for a Humira-biosimilar but commercialization is expected to start after the loss of exclusivity for Humira in the U.S.
To prepare for the loss in Humira sales due to patent exclusivity, AbbVie has developed and is presently marketing its newest immunology drugs, Skyrizi (risankizumab) and Rinvoq (upadacitinib), which position it well for long-term growth.
Rinvoq is approved for five indications in the United States and Europe — RA, psoriatic arthritis, ankylosing spondylitis, atopic dermatitis and ulcerative colitis. Skyrizi is approved in the United States and Europe for two indications – plaque psoriasis and psoriatic arthritis. Skyrizi is also approved in the United States for a third indication, i.e., CD, while a regulatory filing is under review in Europe seeking approval for Skyrizi in CD and a decision is expected by year-end.
Skyrizi and Rinvoq have demonstrated differentiated clinical profiles versus Humira and are already contributing meaningful revenues. Rinvoq and Skyrizi combined have generated $4.6 billion in combined sales in 2021 and $3.25 billion in the first half of 2022.
This strength in revenue is mainly driven by approvals of the drugs in new indications. With these approvals, sales of these drugs could be higher in 2023/2024 and potentially to replace Humira when generics are launched in the United States in 2023. AbbVie expects combined sales of Skyrizi and Rinvoq to be more than $15 billion by 2025.
Apart from immunology franchise, AbbVie also enjoys leadership positions in other key therapeutic areas, including hematologic oncology, neuroscience, aesthetics and eye care.
AbbVie believes that oncology will be its major growth driver over the next 10 years. AbbVie has built a substantial oncology franchise with Imbruvica (hematological cancers) and Venclexta (hematological malignancies), which generated nearly $7.2 billion in 2021 and $3.3 billion in first-half 2022.
AbbVie developed Imbruvica in partnership with Johnson & Johnson JNJ. Per the terms of the partnership, J&J has exclusive license to market the drug outside the United States. The company shares international profits earned from Imbruvica with J&J. Both ABBV and J&J co-exclusively market the drug in the United States
The U.S. sales of Imbruvica are being hurt by lower new patient starts in CLL due to delayed recovery from the pandemic and increasing competition from newer therapies. However, sales are expected to recover in subsequent future quarters as the pandemic is now officially over in the country.
AbbVie also has an exciting and diverse pipeline of promising new therapies in both blood cancers and solid tumors like navitoclax for myelofibrosis, epcoritamab, a CD3xCD20 bispecific, across several B-cell malignancies including diffuse B cell and follicular lymphomas, ABBV-383, a BCMA CD3 bispecific, being studied for multiple myeloma and Teliso-V, a promising c-Met ADC being studied for non-squamous non-small cell lung cancer. AbbVie expects to submit regulatory applications in 2022 for accelerated approval of epcoritamab in patients with relapsed/refractory large B-cell lymphoma.
Other key drugs include Botox Cosmetic (aesthetic use), Juvederm, Botox Therapeutics (neuroscience indications) and Vraylar (schizophrenia and bipolar I disorder), each of which is a driver of sales for the company. The company added Botox to its list following the acquisition of Allergan in 2020. AbbVie’s rationale behind the Allergan deal was to add a new blockbuster product like Botox to its portfolio, ahead of generic competition for Humira.
The company has also launched new migraine drugs, Ubrelvy and Qulipta, with each drug representing a $1 billion-plus peak sales opportunity.
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