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Transformation in R&D Key to Address Hurdles in Biopharma

Biologics-and-Biosimilars

Traditional pharmaceutical companies are focused on expanding their business in the biopharmaceutical industry.

However, this transformation has several challenges, owing to several factors such as stringent regulatory scenario and complexities in R&D of biopharmaceuticals.

This has led players in the biopharmaceutical market to focus better-equipped laboratories and operations in order to develop a robust biopharmaceutical pipeline.

The biopharmaceutical industry is witnessing significant growth with increasing approval and launch of orphan drugs.

For instance, according to Pharmaceutical Research and Manufacturers of America, over 750 orphan drugs were approved in the U.S. in 2018, compared to over 600 in 2017.

Although the prevalence of rare diseases is high in several economies and treatments are available for only very few rare diseases, recent advances are providing important new options to many patients for the first time.

For instance, in August 2018, The U.S. Food and Drug Administration approved Galafold (migalastat), the first oral medication for the treatment of adults with Fabry disease.

Major market players are focused on conducting clinical trials to access the efficacy of biologics. In April 2020, Samsung Biologics signed a contract developing organization agreement with PharmAbcine, a biotechnology company, for developing and manufacturing the PMC-402 pipeline.

The success rate of biologics is higher than small molecule drugs. In the same month, Ansun Biopharma, Inc. announced that investigator-initiated trial of novel COVID-19 treatment with DAS181, a recombinant sialidase with broad antiviral properties, demonstrated positive results.

Moreover, the use of biopharmaceuticals has changed the way several diseases are managed. Treatment for rheumatoid arthritis earlier focused on reducing joint inflammation and failed in the treatment of the symptoms of the disease.

However, the development of biologic disease-modifying antirheumatic drugs have allowed addressing the root cause of inflammation, thereby improves physical functioning and preventing irreversible joint damage.

The mortality rate of HIV/AIDS has witnessed a downward trend. This can be attributed to several developments in the biopharmaceutical sector that include, the approval of fusion inhibitors, C-C chemokine receptor type 5 agonist, and nucleotide analogues. Advancements in the biopharma sector has also aided in mitigating cancer death rates.

In March 2020, Jiangsu Alphamab Biopharmaceuticals Co., Ltd. entered a clinical supply agreement with Pfizer Inc. to advance a clinical study to investigate KN026 in combination with Ibrance (palbociclib), an oral CDK4/6 inhibitor, in patients with previously-treated locally advanced and/or metastatic HER2-positive breast cancer.

The development of direct-acting antivirals (DAAs) has reduced the incidence rate of hepatitis C (HCV).

Moreover, the development of highly effective interferon-free DAAs is expected to reduce the healthcare costs associated with HCV treatment. According to Pharmaceutical Research and Manufacturers of America, the total cumulative savings of HCV treatment since the introduction of highly effective interferon-free DAAs are expected to reach US$ 12 billion by 2020.

The shift from conventional pharmaceuticals to biopharmaceuticals suffers from various challenges. One such challenge is the complexity and difficulty in manufacturing large biological drugs.

Moreover, the production process is costly. Constant monitoring of manufacturing conditions, cell growth, and protein production play a vital role in the production of biopharmaceuticals.

To overcome these issues further developments in the form of new instrumentation, and techniques is required. Market players can also focus on adopting collaboration strategies for R&D in biopharmaceuticals.

About Phase XS: Above article is combined efforts of Phase XS team. Phase XS is a unique analytical platform, which helps you to plan your strategy for biosimilar and biologics development.

It is a proprietary tool of Coherent Market Insights (CMI) that aims to provide meticulous details of clinical trials (Phase 3 and Phase 4) conducted in the U.S. along with the analytical insights from the team of CMI consultants and verified by industry experts.

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